Home-administered tDCS for Treatment of Depression

NCT ID: NCT04781127

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2022-08-10

Brief Summary

This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sessions of 30 minutes each will be delivered over 10 weeks.

Detailed Description

The Soterix Medical 1X1 mini-CT will be used to determine the safety and efficacy of home-based transcranial direct current stimulation (tDCS) in treating unipolar depression. Specifically efficacy will be determined by change in MADRS score from baseline to the 10 week follow-up. Feasibility and compliance will be determined by low drop out rate and percentage of scheduled sessions completed. Self-reported mood scores will be evaluated using the Quick Inventory of Depressive Symptomatology (QIDS-SR) and Quality of Life enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF). All visits will be performed via telephone or video conference. Subjects will be taught to operate the tDCS system and complete a tolerability check. The treatment course will consist of an acute phase of 28 tDCS sessions conducted Monday - Friday over 6 weeks. This is followed by a taper of 4 tDCS sessions spaced 1 week apart. Patients who meet criteria for clinical response (>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months. Mood assessments will be conducted at baseline, 2 weeks, 4 weeks and 6 weeks in the acute treatment phase. In the taper phase, assessments wil be conducted at 1 month (end of taper), 3 and 6 months following completion of the acute phase. All assessments in the acute treatment phase and the taper phase will have a +/- 1 week collection window.

Conditions

Unipolar Depression; Treatment Resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active tDCS

Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator

Group Type: EXPERIMENTAL

Soterix Medical mini-CT tDCS stimulator

Intervention Type: DEVICE

Stimulation will last 30 minutes per day, 5 days per week, for 5 weeks, then 3 days per week for 1 week and then 1 day per week for 4 weeks.

Interventions

Soterix Medical mini-CT tDCS stimulator

Stimulation will last 30 minutes per day, 5 days per week, for 5 weeks, then 3 days per week for 1 week and then 1 day per week for 4 weeks.

Intervention Type: DEVICE

Other Intervention Names

Soterix Medical ElectraRx; Soterix Medical SNAPpad

Eligibility Criteria

Inclusion Criteria

• Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview.
• Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
• Scored at least 20 on the MADRS at trial entry
• Patient's antidepressant medication is stable for at least 30 days prior to MADRS screening
• Female patients are allowed if not pregnant and are using a medically acceptable method of contraception, if of childbearing potential

Exclusion Criteria

• DSM-V-TR psychotic disorder
• Drug or alcohol abuse or dependence in the preceding 3 months
• Concurrent benzodiazepine medication
• High suicide risk
• History of clinically defined neurological disorder or insult
• Metal in the cranium or skull defects
• Subjects with an implanted pump, neurostimulator, cardiac pacemaker or defibrillator
• Skin lesions on scalp at the proposed electrode sites
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: collaborator

Soterix Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abhishek Datta, PhD

Role: PRINCIPAL_INVESTIGATOR

Soterix Medical Inc.

Locations

New York University

New York, New York, United States

Countries

United States

References

Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.

Reference Type: BACKGROUND

PMID: 28657871 (View on PubMed)

Other Identifiers

SMI-F10

Identifier Type: -

Identifier Source: org_study_id