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

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ClinicalTrials.gov Identifier: NCT03708159
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Daniel Blumberger, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: active tDCS + mindfulness meditation Other: sham tDCS + mindfulness meditation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Step-Down Neurostimulation to Maintain Response After Repetitive Transcranial Magnetic Stimulation (rTMS) Using Transcranial Direct Current Stimulation (tDCS): The START Study
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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.
Device: active tDCS + 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 Name: Soterix tDCS mini-Clinical Trials system (mini-CT) - active

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.
Other: sham tDCS + 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 Name: Soterix tDCS mini-Clinical Trials system (mini-CT) - sham




Primary Outcome Measures :
  1. 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 ]
    • 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708159


Contacts
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Contact: Dov Millstone 416-535-8501 ext 36434 dov.millstone@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Dov Millstone    416-535-8501 ext 36434    dov.millstone@camh.ca   
Principal Investigator: Zafiris J Daskalakis, MD, PhD         
Principal Investigator: Daniel M Blumberger, MD         
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada
Contact: Terri Cairo    416-603-5800 ext 4950      
Principal Investigator: Jonathan Downar, MD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
University Health Network, Toronto
Investigators
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Principal Investigator: Daniel Blumberger, MD, MSc Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: Daniel Blumberger, Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03708159     History of Changes
Other Study ID Numbers: 063-2018
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Blumberger, Centre for Addiction and Mental Health:
tDCS
Mindfulness meditation
Home-based tDCS
rTMS

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms