Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study

University of California San Diego

Status: Enrolling

Conditions: Treatment Resistant Depression (TRD); Major Depressive Disorder (MDD)

Treatments: Device: Spaced Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07217223

812687 (Registry Identifier)

Details and patient eligibility

About

The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies.

PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. People between the ages of 18 and 85 at the time of screening.
2. Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
3. Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
4. Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant Treatment History Form (ATHF) score ≥ 3 or ) or shown intolerance to at least two inadequate trials (score 1 or 2), without psychiatric illness due to a general medical condition.
5. Stable internet connection and a device compatible with Microsoft Teams.

Exclusion criteria

1. History of psychotic or bipolar disorder or depression with psychotic features;
2. Significant borderline personality disorder;
3. Significant comorbid obsessive-compulsive or post-traumatic stress:
4. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
5. Clinically significant suicidality disorder;
6. Chronic depression (defined as of over 5 years duration);
7. Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
8. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms;
9. Unstable medical illness;
10. Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
11. History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response;
12. Require a benzodiazepine with a dose > lorazepam 2 mg/day;
13. dermatological conditions contraindicating tDCS;
14. Non-correctable sensory impairments;
15. Inability to consent or participate as an outpatient

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Spaced Transcranial Direct Current Stimulation Treatment

Experimental group

Description:

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. tDCS sessions will be self-administered at home under the supervision of a trained clinical research coordinator. Each treatment day will consist of five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours per day. Other Names: * tDCS * Soterix Medical miniCT

Treatment:

Device: Spaced Transcranial Direct Current Stimulation (tDCS)