- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708159
Maintenance of Response After rTMS for Depression Using tDCS (START)
Step-Down Neurostimulation to Maintain Response After Repetitive Transcranial Magnetic Stimulation (rTMS) Using Transcranial Direct Current Stimulation (tDCS): The START Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Home-based tDCS (active vs. sham) will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months, in combination with mindfulness mediation for the duration of tDCS each treatment. Subjects who miss 4 consecutive treatment days or 20 percent of total treatments will be exit the treatment intervention as it is our intention to encourage compliance with the proposed treatments to maintain optimal wellness.
Aim 1. To investigate the efficacy of at home maintenance tDCS for patients with MDD who have responded to a successful acute course of rTMS.
Hypothesis 1. Patients receiving tDCS will have a higher proportion of sustained responders or remitters after 6 months compared to sham tDCS.
Exploratory Aim 2. To investigate clinical predictors of sustained response to rTMS using tDCS Hypothesis 2. Remitters and those not on benzodiazepines will be associated with greater likelihood of sustained response.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dov Millstone
- Phone Number: 36434 416-535-8501
- Email: dov.millstone@camh.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6J 1H4
- Centre for Addiction and Mental Health
-
Toronto, Ontario, Canada
- Toronto Western Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- History of Major Depressive Disorder with most recent depressive episode treated with acute rTMS
- Individuals capable to provide consent who are receiving care as outpatients/research participants, and are now responders or remitters (defined by 50% improvement on any depression scale since the beginning of treatment and HRSD-17 ≤ 15, or an HRSD-17 score <8).
- Age 18-85, inclusive.
Exclusion Criteria:
- History of a DSM-IV substance use disorder within the past three months
- Concomitant major unstable medical illness
- DSM-IV diagnosis of any psychotic disorder, obsessive compulsive disorder, or post-traumatic stress disorder (current or within the last year) as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
- DSM-IV diagnosis of personality disorder as assessed by a study investigator
- Any significant neurological disorder (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis)
- Presenting with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, Cushing's disease)
- Any intracranial implant (e.g., aneurysm clips, shunts, cochlear implants) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- Any dermatological disorder or any cuts/broken skin in the scalp region that may affect the safe delivery of the tDCS stimulus
- Requiring a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of tDCS
- The inability to communicate in spoken and written English fluently enough to complete the neuropsychological tests due to a language barrier or a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
- Cognitive impairment or physical impairment such that they are unable to learn to, or physically unable to apply tDCS to their scalp without assistance (after training).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: active tDCS + mindfulness meditation
Participants randomized to this group will receive active tDCS 3 times a week for approximately 3 months and then weekly for 3 months.
After completing baseline procedures they will be trained how to apply the tDCS device themselves.
The first 3-6 treatments will be completed at the hospital to ensure proper and safe application.
Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times.
Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation.
|
Participants are provided with an activation code.
This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively).
These devices will be set to active.
Each tDCS sessions will be delivered in combination with a guided mindfulness meditation that we have recorded.
Other Names:
|
Sham Comparator: sham tDCS + mindfulness meditation
Participants randomized to this group will receive sham tDCS 3 times a week for approximately 3 months and then weekly for 3 months.
After completing baseline procedures they will be trained how to apply the tDCS device themselves.
The first 3-6 treatments will be completed at the hospital to ensure proper and safe application.
Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times.
Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation.
|
Participants are provided with an activation code.
This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively).
These devices will be set to sham.
Each tDCS sessions will be delivered in combination with a guided mindfulness meditation that we have recorded.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients maintaining remission of depressive symptoms or response to rTMS treatments as measured by the Hamilton Rating Scale for Depression - 17 Hamilton Rating Scale for Depression (17-item version)
Time Frame: 6 months
|
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of responders and remitters who relapse
Time Frame: 6 months
|
Relapse defined separately for responders and remitters Responders who experience >50% worsening of their HRSD-17 scores from baseline, over 2 consecutive assessments, will discontinue tDCS and discuss treatment options with a study physician.
Remitters will discontinue tDCS and discuss treatment options if they have an HRSD-17 score of >18 over 2 consecutive assessments separated by at least 1 week.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daniel Blumberger, MD, MSc, Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 063-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on active tDCS + mindfulness meditation
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedAttention Deficit Disorder With HyperactivityBrazil
-
University of Sao Paulo General HospitalFederal University of São PauloCompletedStress | DNA Methylation | Mindfulness | Psychological Well-being | Learning and MemoryBrazil
-
The University of Texas Health Science Center,...CompletedKnee OsteoarthritisUnited States
-
The University of Texas Health Science Center,...National Center for Complementary and Integrative Health (NCCIH); Sam Houston... and other collaboratorsRecruitingSpinal Cord InjuriesUnited States
-
Oregon Health and Science UniversityCompleted
-
Centre for Addiction and Mental HealthUniversity of TorontoCompletedMood Disorders | Anxiety Disorders | tDCS | Stress Reduction | Transcranial Direct Current StimulationCanada
-
University Hospital, AngersNot yet recruitingLateral Sclerosis Amyotrophy | Mindfulness Meditation
-
University of Illinois at Urbana-ChampaignNorthwestern University Feinberg School of Medicine; Southern Illinois University and other collaboratorsNot yet recruitingPain, Postoperative | Depression, Unipolar
-
Universiti Tunku Abdul RahmanRecruiting