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Efficacy of Biofeedback in the Treatment of Tic Disorder

  • Time Stamp: May 31, 2024
  • Source Node: 173881

Studies

Study First Submitted Date 2022-03-18
Study First Posted Date 2022-05-05
Last Update Posted Date 2022-10-24
Start Month Year June 1, 2024
Primary Completion Month Year December 31, 2026
Verification Month Year October 2022
Verification Date 2022-10-31
Last Update Posted Date 2022-10-24

Detailed Descriptions

Sequence: 20802855
Description This study intends to investigate the efficacy of EEG biofeedback and drug therapy on clinical symptoms, cognitive flexibility and quality of life in chronic tic disorder and Tourette syndrome through a randomized controlled study.

Facilities

Sequence: 200793616
Name Children's hospital of Fundan University
City Shanghai
State Shanghai
Zip 201102
Country China

Facility Contacts

Sequence: 28220306
Facility Id 200793616
Contact Type primary
Name Ding Qiang, master
Email johndean@foxmail.com
Phone 18818239447
Phone Extension 201102

Browse Interventions

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Mesh Term Aripiprazole Mesh Term Antidepressive Agents Mesh Term Psychotropic Drugs Mesh Term Antipsychotic Agents Mesh Term Tranquilizing Agents Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Dopamine Agonists Mesh Term Dopamine Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Serotonin 5-HT1 Receptor Agonists Mesh Term Serotonin Receptor Agonists Mesh Term Serotonin Agents Mesh Term Serotonin 5-HT2 Receptor Antagonists Mesh Term Serotonin Antagonists Mesh Term Dopamine D2 Receptor Antagonists Mesh Term Dopamine Antagonists
Downcase Mesh Term aripiprazole Downcase Mesh Term antidepressive agents Downcase Mesh Term psychotropic drugs Downcase Mesh Term antipsychotic agents Downcase Mesh Term tranquilizing agents Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term dopamine agonists Downcase Mesh Term dopamine agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term serotonin 5-ht1 receptor agonists Downcase Mesh Term serotonin receptor agonists Downcase Mesh Term serotonin agents Downcase Mesh Term serotonin 5-ht2 receptor antagonists Downcase Mesh Term serotonin antagonists Downcase Mesh Term dopamine d2 receptor antagonists Downcase Mesh Term dopamine antagonists
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52378172
Name Tic Disorders
Downcase Name tic disorders

Id Information

Sequence: 40306145
Id Source org_study_id
Id Value TD_BF_RCT20220318

Countries

Sequence: 42728769
Name China
Removed False

Design Groups

Sequence: 55823438 Sequence: 55823439
Group Type Experimental Group Type Active Comparator
Title Biofeedback therapy Title Drug therapy
Description three times a week, every other day interval, 30 minutes each time, each subject received 20 biofeedback training (using the Infiniti3000A biofeedback system Patients in the theta group decreased the theta amplitude at Cz. Patients in the theta group received positive feedback when their theta activity was below the feedback threshold. Description Considering the patients with chronic tic disorder (chronic motor or vocal tic disorder or Tourette's disorder), aripiprazole was selected as a single drug with constant dose during the treatment. In case of extrapyramidal side effects, benhexol was given to reduce the extrapyramidal side effects, and the dosage and duration of medication were recorded

Interventions

Sequence: 52688379 Sequence: 52688380
Intervention Type Drug Intervention Type Device
Name Drug Aripiprazole Name biofeedback
Description Considering the patients with chronic tic disorder (chronic motor or vocal tic disorder or Tourette's disorder), aripiprazole was selected as a single drug with constant dose during the treatment. In case of extrapyramidal side effects, benhexol was given to reduce the extrapyramidal side effects, and the dosage and duration of medication were recorded Description Biofeedback therapy Biofeedback therapy, three times a week, every other day interval, 30 minutes each time, each subject received 20 biofeedback training（using the Infiniti3000A biofeedback system，Thought Technology Ltd.）.Patients in the theta group decreased the theta amplitude at Cz. Patients in the theta group received positive feedback when their theta activity was below the feedback threshold.

Keywords

Sequence: 80151470 Sequence: 80151471 Sequence: 80151472 Sequence: 80151473
Name biofeedback Name drug therapy Name Clinical Efficacy Name Cognitive flexibility
Downcase Name biofeedback Downcase Name drug therapy Downcase Name clinical efficacy Downcase Name cognitive flexibility

Design Outcomes

Sequence: 178143717 Sequence: 178143718 Sequence: 178143719 Sequence: 178143720 Sequence: 178143721 Sequence: 178143722 Sequence: 178143723 Sequence: 178143724 Sequence: 178143725 Sequence: 178143726 Sequence: 178143727 Sequence: 178143728 Sequence: 178143729 Sequence: 178143730 Sequence: 178143731 Sequence: 178143732
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Yale global tic severity scale Measure Yale global tic severity scale Measure Yale global tic severity scale Measure Yale global tic severity scale Measure Wisconsin Card Sorting Test Measure Wisconsin Card Sorting Test Measure Wisconsin Card Sorting Test Measure Wisconsin Card Sorting Test Measure Color-word Stroop task Measure The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Measure The parent version of Swanson, Nolan, and Pelham-IV(SNAP-IV) Measure Children' s Depression Inventory(CDI) Measure The Screen for Child Anxiety Related Emotional Disorders(SCARED) Measure Conners' Parent Rating Scale-Revised（CPRS-R） Measure The Clinical Global Impression-severity scale Measure Clinical Global Impressions-Improvement scale
Time Frame baseline assessment (T0) Time Frame assessment after 4 weeks of treatment (T1) Time Frame assessment after 8 weeks of treatment (T2) Time Frame 3-month follow-up after completion of treatment (T3). Time Frame baseline assessment (T0) Time Frame assessment after 4 weeks of treatment (T1) Time Frame assessment after 8 weeks of treatment (T2) Time Frame 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，aseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，aseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3) Time Frame It's a repeated measurement variable，assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Description Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening. Description Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening. Description Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening. Description Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening. Description The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance. Description The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance. Description The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance. Description The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance. Description The Stroop task requires participants to name the ink color of a series of color words. In the congruent condition, the color name corresponds exactly to the color of each letter; in the incongruent condition, the printed word and the actual color of each letters are different. When subjects are required to report the ink color of the word, greater difficulty is experienced when they are in the incongruent condition. This difficulty can be measured by the increase in the amount of time required to complete the task (the Stroop interference effect). The measure of executive ability is the relative response delay in the Stroop interference condition as measured by response time (RT) in the incongruent condition minus RT in the neutral condition. Description The CY-BOCS evaluates the severity of obsessions and compulsions, using ten items across five dimensions (time occupied by symptoms, interference, distress, resistance and degree of control over symptoms). The total severity score can range from 0 to 40. CY-BOCS total scores in the range of 14-24 are considered moderate, 25-30 moderate-severe and over 30 severe Description It contains 26 items and is scored on a 0-3 Likert scale. The scale consists of three subscales, which are three parts: attention deficit, hyperactivity/impulsivity, and oppositional defiance, and can be used for the assessment of ADHD symptoms in tic symptom comorbidity in this study. Description There are 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; children and adolescents select the one that characterized their symptoms best during the past 2 weeks. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state. Description The SCARED is a 41-item self-report measure designed to screen for DSM-IV anxiety disorders. The SCARED includes 5 factors: somatic/panic (13 items; e.g., "When I feel frightened, it is hard to breathe"), generalized anxiety (9 items; e.g., "I worry about other people liking me"), separation anxiety (8 items; e.g., "I get scared if I sleep away from home"), social phobia (7 items; e.g., "I don't like to be with people I don"t know well"), and school phobia (4 items; e.g., "I get headaches when I am at school"). The participants rated the items of each factor on a 3-point scale (0 = not true or hardly ever true, 1 = sometimes true, and 2 = true or often true). The SCARED total score, derived by adding the responses of the 41 items, ranges from 0 to 82. Description It is suitable for children aged 3 – 16 years, and a total of 48 items in this scale include six factors: conduct problems, learning problems, psychosomatic problems, impulsive-hyperactivity, anxiety, and hyperactivity index, with a total of 48 items, which are scored on a 0-3 four-level scale. Description The severity of illness subscale is designed to acquaint the patient's severity of symptoms with those of other people experiencing the same mental ailment. The CGI-S rates this severity of a 1-7 scale, with (1) representing normal symptoms, meaning the patient is not ill. The highest on the scale, (7), represents patients among the most severely ill. Right in the middle at (4), a patient will be defined as moderately ill. Description The global improvement subscale allows the practitioner to create a comparative improvement based on the baseline of the first test. These changes reflect how symptoms have or have no improves due to treatment. The 7-point CGI-I scale rates improvement with a (1) representing a 'very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.

Browse Conditions

Sequence: 194273957 Sequence: 194273958 Sequence: 194273959 Sequence: 194273960 Sequence: 194273961 Sequence: 194273962 Sequence: 194273963 Sequence: 194273964 Sequence: 194273965
Mesh Term Tics Mesh Term Tic Disorders Mesh Term Dyskinesias Mesh Term Neurologic Manifestations Mesh Term Nervous System Diseases Mesh Term Movement Disorders Mesh Term Central Nervous System Diseases Mesh Term Neurodevelopmental Disorders Mesh Term Mental Disorders
Downcase Mesh Term tics Downcase Mesh Term tic disorders Downcase Mesh Term dyskinesias Downcase Mesh Term neurologic manifestations Downcase Mesh Term nervous system diseases Downcase Mesh Term movement disorders Downcase Mesh Term central nervous system diseases Downcase Mesh Term neurodevelopmental disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48512475 Sequence: 48512476
Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Children's Hospital of Fudan University Name Shanghai Normal University

Central Contacts

Sequence: 12061714
Contact Type primary
Name Ding Qiang, master
Phone 18818239447
Email johndean@foxmail.com
Phone Extension 201102
Role Contact

Design Group Interventions

Sequence: 68430463 Sequence: 68430464
Design Group Id 55823439 Design Group Id 55823438
Intervention Id 52688379 Intervention Id 52688380

Eligibilities

Sequence: 30885090
Gender All
Minimum Age 8 Years
Maximum Age 16 Years
Healthy Volunteers No
Criteria Inclusion Criteria: Meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition,DSM-5) for chronic tic disorder or Tourette syndrome（TS）; Ethnic group is Han nationality; Aged 8 ~ 16 years old; otal IQ of Wechsler Intelligence Scale for Children ≥ 80 points for subjects; Symptom severity score in Yale Global Severity Scale (YGTSS), TS patients > 13, CTD > 9; Did not receive any drug (including traditional Chinese medicine) treatment 4 weeks before enrollment; Obtain written informed consent from children and guardians Exclusion Criteria: Epilepsy, cardiovascular disease Patients with schizophrenia, mental retardation, autism spectrum disorder, bipolar disorder and major depression who meet the DSM-5 diagnostic criteria; Receiving systematic traditional Chinese medicine treatment one month before enrollment or currently; Receiving systematic psychotherapy one month before enrollment or currently; Receive systematic physical therapy one month before enrollment or currently Those who cannot follow the doctor's advice or refuse to cooperate; Those with obvious abnormal laboratory test results (AST or ALT ≥ 2 times of the upper limit of normal value; bun ≥ 1.5 times of the upper limit of normal value; Cr ≥ 1.2 times of the upper limit of normal value); Prolongation of QTc interval (QTc ≥ 450 ms in men or ≥ 470 MS in women);
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254114749
Number Of Facilities 1
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 8
Maximum Age Num 16
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 8
Number Of Secondary Outcomes To Measure 8

Designs

Sequence: 30630855
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28997435
Responsible Party Type Principal Investigator
Name Ding Qiang
Title Clinical Psychotherapist
Affiliation Children's Hospital of Fudan University
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