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 |
| 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) |