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Predicting Illness Trajectories In Fully Remitted Major Depression Using Concurrent TBS/fNIRS

Studies

Study First Submitted Date 2022-09-14
Study First Posted Date 2022-10-13
Last Update Posted Date 2023-03-08
Start Month Year January 2024
Primary Completion Month Year December 2026
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-08

Conditions

Sequence: 52251907 Sequence: 52251908
Name Major Depression in Remission Name Healthy
Downcase Name major depression in remission Downcase Name healthy

Id Information

Sequence: 40217504
Id Source org_study_id
Id Value HSEARS20220812002

Design Groups

Sequence: 55683680 Sequence: 55683681
Group Type Experimental Group Type Other
Title rMDD group Title Healthy control group
Description Participants with remitted MDD who will receive concurrent TBS/fNIRS with iTBS and followed by cTBS after one hour. This group will also receive follow-up telephone interviews every 3 months for 2 years to monitor major depressive episode recurrence. Description Healthy participants who will receive TBS/fNIRS with iTBS and followed by cTBS after one hour. No follow-up interviews will be conducted for this group.

Interventions

Sequence: 52564800 Sequence: 52564801
Intervention Type Device Intervention Type Other
Name Theta-burst stimulation (TBS) Name telephone interviews
Description TBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz), as described previously. iTBS consists of 2-second trains with an inter-train interval of 8 seconds. The investigators will repeat the trains (30 pulses; 10 bursts) 20 times to reach a total number of 600 pulses (3x10x20). cTBS will comprise uninterrupted bursts to reach a total of 600 pulses. Concurrent TBS/fNIRS stimulation will be applied over the left (iTBS) and right (cTBS) DLPFC at an intensity of 90% resting motor threshold (RMT). This corresponds to ~110% of the active motor threshold. Stimulation at 90% RMT will also ensure compliance, reduce sensory discomfort and minimize dropout rates. Still, scalp discomfort will be recorded directly after the stimulation. The stimulation site over the DLPFC will be determined using the international 10-20 system and correspond to the F3 label. Description Telephone interviews will be conducted at the follow-up stage. RMDD group will receive follow-up telephone interviews every 3 months for 2 years to monitor major depressive episode recurrence

Keywords

Sequence: 79983087 Sequence: 79983088 Sequence: 79983089 Sequence: 79983090 Sequence: 79983091
Name Theta-burst stimulation Name Remitted depression Name Relapse prediction Name Functional NIRS Name Concurrent TBS/fNIRS
Downcase Name theta-burst stimulation Downcase Name remitted depression Downcase Name relapse prediction Downcase Name functional nirs Downcase Name concurrent tbs/fnirs

Design Outcomes

Sequence: 177674707 Sequence: 177674708 Sequence: 177674706
Outcome Type primary Outcome Type secondary Outcome Type primary
Measure Oxyhemoglobin (HbO) change compared to baseline Measure Hemoglobin (Hb) change compared to baseline Measure Recurrence of a major depressive episode
Time Frame During and within 3 minutes post TBS-fNIRS measurement. Time Frame During and within 3 minutes post TBS-fNIRS measurement Time Frame Up to 2 years.
Description Primary imaging outcome measure: TBS-induced HbO change in the dorsolateral prefrontal cortex (DLPFC) during and after stimulation. Description Secondary Imaging Outcome Measure: TBS-induced Hemoglobin (Hb) change in the dorsolateral prefrontal cortex (DLPFC) during and after stimulation Description Primary clinical outcome measure: recurrence of a major depressive episode (based on MINI and PhQ-9 ≥ 5).

Browse Conditions

Sequence: 193795571 Sequence: 193795572 Sequence: 193795573 Sequence: 193795574 Sequence: 193795575 Sequence: 193795576
Mesh Term Depression Mesh Term Depressive Disorder Mesh Term Depressive Disorder, Major Mesh Term Behavioral Symptoms Mesh Term Mood Disorders Mesh Term Mental Disorders
Downcase Mesh Term depression Downcase Mesh Term depressive disorder Downcase Mesh Term depressive disorder, major Downcase Mesh Term behavioral symptoms Downcase Mesh Term mood disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48395069
Agency Class OTHER
Lead Or Collaborator lead
Name The Hong Kong Polytechnic University

Overall Officials

Sequence: 29329283
Role Principal Investigator
Name Georg S. Kranz, PhD
Affiliation The Kong Kong Polytechnic University

Central Contacts

Sequence: 12027599
Contact Type primary
Name Georg S Kranz, PhD
Phone +852 2766
Email georg.kranz@polyu.edu.hk
Phone Extension 4838
Role Contact

Design Group Interventions

Sequence: 68258044 Sequence: 68258045 Sequence: 68258046
Design Group Id 55683681 Design Group Id 55683680 Design Group Id 55683680
Intervention Id 52564800 Intervention Id 52564800 Intervention Id 52564801

Eligibilities

Sequence: 30812459
Gender All
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria: a clinical diagnosis of recurrent depressive disorder by an experienced psychiatrist but currently in full remission (ICD 11, 6A71.7) according to results of the Mini International Neuropsychiatric Interview (MINI) and the Patient Health Questionnaire (PHQ-9), with a score ≤ 4; at least two previous MDEs within the last 10 years; no or stable (≥4 weeks) psychopharmacological medication. Exclusion Criteria: severe internal diseases; neurological disorders or a history of severe head injuries; current psychiatric comorbidities, including addiction; pregnancy; common fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures, and antiepileptics and benzodiazepines corresponding to a dose of >1 mg lorazepam/d. Potential participants taking antidepressants will be included if there has been no recent change to either dosage or medication (within 4 weeks).
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254054769
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30558432
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26710752
Intervention Id 52564800
Name Repetitive transcranial magnetic stimulation (rTMS)

Responsible Parties

Sequence: 28924824
Responsible Party Type Principal Investigator
Name Dr Georg Kranz
Title Assistant Professor
Affiliation The Hong Kong Polytechnic University

Ipd Information Types

Sequence: 3340468 Sequence: 3340469 Sequence: 3340470
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Informed Consent Form (ICF)