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Transcranial Alternating Current Stimulation for Treatment-Resistant Depression

NCT06172413 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-31

No results posted yet for this study

Summary

This trial aims to investigate the effect of twice-daily 15 mA transcranial alternating current stimulation (tACS) through three conductive electrodes attached to the scalp in subjects with treatment-resistant depression (TRD). Two hundred adult subjects with TRD will be included in this randomized, double-blind, parallelized, multi-centre study. The primary outcome is the change of the Montgomery-Asberg Depression Rating Scale (MADRS) after four weeks of tACS.

Conditions

  • Treatment-Resistant Depression

Interventions

DEVICE

transcranial alternating current stimulation (tACS)

Three conductive electrodes will be applied to the scalp: one 4.45 × 9.53 cm electrode placed over the forehead (Fpz, Fp1, and Fp2 in the 10/20 international placement system) and two 3.18 × 3.81 cm electrodes over the mastoid areas. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. It is a square-wave with an average amplitude of 15 mA and is equally distributed from the frontal region to the mastoid areas (amplitudes are reported as zero-to-peak). Each subject will receive 40 sessions of tACS intervention during 4 consecutive weeks at a fixed day time twice per day (once in morning and afternoon, respectively) from Monday through Friday. Each session lasts 40 min.

DEVICE

Sham tACS

Sham tACS

Sponsors & Collaborators

  • Ningcheng Center Hospital

    collaborator UNKNOWN

  • Changning Mental Health Center

    collaborator UNKNOWN

  • Tianjin Anding Hospital

    collaborator OTHER

  • Kangning Hospital, Ningbo University

    collaborator UNKNOWN

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Hongxing Wang, MD & PhD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-12-31
Completion
2025-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06172413 on ClinicalTrials.gov