NCT05205915

Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Neuroelectrics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

Detailed description

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session. The main objective of the study is to assess the feasibility and safety of home-based tDCS for patients with MDD. The treatment course will consist of an acute phase of 28 tDCS sessions, conducted daily (7 days per week) over 4 weeks. Thereafter, participants 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. Three tDCS sessions applied once every other day. 2. Three tDCS sessions applied once every third day. 3. Three tDCS sessions applied once every fourth day.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	tDCS intervention applied by Starstim device	Stimulation will be applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents). The montage has been designed to optimize anodal stimulation in the desired target area while avoiding stimulation off target.

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-01-25
• Last updated: 2022-10-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study