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Maintenance of Response After rTMS for Depression Using tDCS (START)

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
active tDCS + mindfulness meditation
sham tDCS + mindfulness meditation
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring tDCS, Mindfulness meditation, Home-based tDCS, rTMS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of Major Depressive Disorder with most recent depressive episode treated with acute rTMS
  2. 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).
  3. Age 18-85, inclusive.

Exclusion Criteria:

  1. History of a DSM-IV substance use disorder within the past three months
  2. Concomitant major unstable medical illness
  3. 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)
  4. DSM-IV diagnosis of personality disorder as assessed by a study investigator
  5. 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)
  6. 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)
  7. 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
  8. Any dermatological disorder or any cuts/broken skin in the scalp region that may affect the safe delivery of the tDCS stimulus
  9. 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
  10. 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).
  11. 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).

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting
  • Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active tDCS + mindfulness meditation

sham tDCS + mindfulness meditation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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)
This scale is used to quantify the severity of symptoms of depression Scale range: 0-52 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Secondary Outcome Measures

Proportion of responders and remitters who relapse
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.

Full Information

First Posted
October 12, 2018
Last Updated
March 4, 2022
Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03708159
Brief Title
Maintenance of Response After rTMS for Depression Using tDCS
Acronym
START
Official Title
Step-Down Neurostimulation to Maintain Response After Repetitive Transcranial Magnetic Stimulation (rTMS) Using Transcranial Direct Current Stimulation (tDCS): The START Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a double-blind, multi-site, randomized controlled trial (RCT) that will recruit 200 participants.The purpose of the RCT will be to evaluate the efficacy of transcranial direct current stimulation (tDCS) in combination with mindfulness meditation compared to sham tDCS to maintain wellness following an acute course of repetitive transcranial magnetic stimulation (rTMS) for up to 6 months.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
tDCS, Mindfulness meditation, Home-based tDCS, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS + mindfulness meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
sham tDCS + mindfulness meditation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
active tDCS + mindfulness meditation
Other Intervention Name(s)
Soterix tDCS mini-Clinical Trials system (mini-CT) - active
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham tDCS + mindfulness meditation
Other Intervention Name(s)
Soterix tDCS mini-Clinical Trials system (mini-CT) - sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
This scale is used to quantify the severity of symptoms of depression Scale range: 0-52 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of responders and remitters who relapse
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dov Millstone
Phone
416-535-8501
Ext
36434
Email
dov.millstone@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Blumberger, MD, MSc
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dov Millstone
Phone
416-535-8501
Ext
36434
Email
dov.millstone@camh.ca
First Name & Middle Initial & Last Name & Degree
Zafiris J Daskalakis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Daniel M Blumberger, MD
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri Cairo
Phone
416-603-5800
Ext
4950
First Name & Middle Initial & Last Name & Degree
Jonathan Downar, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.net/research
Description
Description Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

Learn more about this trial

Maintenance of Response After rTMS for Depression Using tDCS

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