NCT06730841

Dose-Optimized and Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the feasibility, safety, and tolerability of an innovative approach to treating Major Depressive Disorder (MDD), particularly in cases where patients have not responded well to traditional therapies. Specifically, the objective is to evaluate the antidepressant effects of a Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS) protocol in participants with treatment-resistant depression (TRD) compared to spaced tDCS only and sham tDCS in a 3-arm randomized controlled trial (RCT). The proposed method involves applying low-intensity electrical currents through the scalp in a manner that is both more intense and more frequently spaced than standard treatments. This approach is hypothesized to lead to a significant reduction in depressive symptoms. Participants in the study will be randomly assigned to one of three groups: the experimental group receiving the DOS-tDCS treatment, a group receiving spaced tDCS only, or a control group receiving a sham (placebo) treatment. Outcomes will be measured over a period of six weeks. The study's goal is to offer a potentially more accessible and effective treatment option for individuals who have not benefited from existing MDD therapies.

Conditions

• Treatment Resistant Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Dose-Optimized and Spaced Transcranial Direct Current Stimulation	tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity. This group will be treated using a stimulation intensity of up to 4 milliamp (mA). Participants will first complete an acute intensive induction phase consisting of daily treatment every weekday over 2 weeks (10 days total) followed by a consolidation phase consisting of weekly treatments (once a week) over 4 additional weeks (6 weeks total).
DEVICE	Spaced Transcranial Direct Current Stimulation	tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity. This group will be treated using a stimulation intensity of 2 mA. Participants will first complete an acute intensive induction phase consisting of daily treatment every weekday over 2 weeks (10 days total) followed by a consolidation phase consisting of weekly treatments (once a week) over 4 additional weeks (6 weeks total).
DEVICE	Sham Transcranial Direct Current Stimulation	tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. This group will be treated using sham stimulation. Participants will first complete an acute intensive induction phase consisting of daily treatment every weekday over 2 weeks (10 days total) followed by a consolidation phase consisting of weekly treatments (once a week) over 4 additional weeks (6 weeks total).

Timeline

• Start date: 2024-09-26
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2024-12-12
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study