NCT04799405

Home-based tDCS in Major Depressive Disorder

Supervised Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hebrew SeniorLife · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose a study of telehealth supervised, caregiver-delivered, home-based transcranial direct current stimulation (tDCS) for antidepressant treatment of patients with an acute depressive episode.

Detailed description

This is an open-label pilot feasibility telemedicine study. This pilot will involve a total of 37 stimulations sessions / at home visits (30- minute sessions of multichannel excitatory tDCS targeting the left DPFC) and the maintenance of a daily treatment diary to be completed by the subjects immediately after enrollment and 12 weeks following the last study visit.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	tDCS	Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions. Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows: 1. First taper phase: three 30 minutes tDCS sessions applied every other day; 2. Second taper phase: three 30 minutes tDCS sessions applied one every third day; 3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.

Timeline

• Start date: 2020-09-24
• Primary completion: 2021-07-02
• Completion: 2021-07-02
• First posted: 2021-03-16
• Last updated: 2022-03-24
• Results posted: 2022-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study