NCT03708159

Maintenance of Response After rTMS for Depression Using tDCS

Step-Down Neurostimulation to Maintain Response After Repetitive Transcranial Magnetic Stimulation (rTMS) Using Transcranial Direct Current Stimulation (tDCS): The START Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2018-09-24
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2018-10-17
• Last updated: 2024-02-20

Locations

2 sites across 1 country: Canada