Maintenance of Response After rTMS for Depression Using tDCS

NCT03708159 | Completed

• 1 other identifier: 063-2018
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder

Keywords

tDCS; Mindfulness meditation; Home-based tDCS; rTMS

Outcome Measures

Primary Outcomes (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)

  * 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)

  6 months

Secondary Outcomes (1)

• Proportion of responders and remitters who relapse

  6 months

Study Arms (2)

active tDCS + mindfulness meditation

EXPERIMENTAL

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

sham tDCS + mindfulness meditation

SHAM COMPARATOR

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

Interventions

active tDCS + mindfulness meditation DEVICE

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.

Also known as: Soterix tDCS mini-Clinical Trials system (mini-CT) - active

active tDCS + mindfulness meditation

sham tDCS + mindfulness meditation OTHER

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.

Also known as: Soterix tDCS mini-Clinical Trials system (mini-CT) - sham

sham tDCS + mindfulness meditation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Related Links

• Description Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mindfulness; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daniel Blumberger, MD, MSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: September 24, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)