Transcranial Alternating Current Stimulation for Treatment-Resistant Depression

NCT ID: NCT06172413

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-03-31

Brief 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.

Detailed Description

This is an 8-week, multicenter, double-blind, sham-controlled, randomized, parallel-group trial.

TRD is defined as failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire (MGH-ATRQ). Patients will be randomized if they remain moderately ill, assessed by Hamilton Depression Scale-item 17 (HAMD-17) score ≥ 20. The primary outcome is a change in the MADRS total score after four weeks of tACS.

"Remission" is defined as MADRS total score ≤10 at Week 4 and Week 8. "Response" is a ≥50% reduction in MADRS total score from baseline to Week 4 and Week 8.

All participants will receive 40 sessions with stimulation at 77.5 Hz and 15 mA (Active group) or sham stimulation (Sham group).

Each session will last 40 minutes from Monday to Friday at a fixed daytime interval for four continuous weeks.

Conditions

Treatment-Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active transcranial alternating current stimulation (tACS)

true stimulation.

Group Type: EXPERIMENTAL

transcranial alternating current stimulation (tACS)

Intervention Type: DEVICE

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.

Sham tACS

no active stimulation

Group Type: SHAM_COMPARATOR

Sham tACS

Intervention Type: DEVICE

Sham tACS

Interventions

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.

Intervention Type: DEVICE

Sham tACS

Sham tACS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 18-65 years old;

2. able to provide written informed consent;

3. had a diagnosis of major depression disorder (MDD) (recurrent episodes) without psychotic features in compliance with the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;

4. failure to respond to at least two antidepressant medication trials based on the MGH-ATRQ;

5. ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;

6. scored≥20 on the Hamilton Depression Scale-item 17 (HAMD-17) at baseline.

Exclusion Criteria

1. Axis I psychiatric disorders, including schizophrenia, bipolar disorder, manic episodes, anxiety disorders (panic disorder, generalized anxiety disorder, and social anxiety disorder), post-traumatic stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, psychosis over the previous six months, and any disorders in Axis II (borderline personality disorder, antisocial personality disorder, schizotypal personality disorder, and narcissistic personality disorder);

2. a treatment history of electroconvulsive therapy (ECT), modified ECT, transcranial direct current stimulation, tACS, deep brain stimulation, and transcranial magnetic stimulation (TMS);

3. risk for suicide (defined as a score of ≥ 3 on the suicide item of HAMD-17);

4. known allergy to electrode materials;

5. inability to communicate with researchers fluently;

6. traumatic brain injury;

7. cerebrovascular or cardiovascular stents;

8. substance use disorder (abuse or dependence, as defined by DSM-IV-TR) in the previous six months;

9. for females, pregnant or breastfeeding, or females of childbearing potential refused to use reliable contraceptive methods during the study;

10. dementia (as defined by Short Blessed > 10 and/or clinical evidence of dementia);

11. participated in other clinical research within three months before enrollment in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningcheng Center Hospital

UNKNOWN

Sponsor Role: collaborator

Changning Mental Health Center

UNKNOWN

Sponsor Role: collaborator

Tianjin Anding Hospital

OTHER

Sponsor Role: collaborator

Kangning Hospital, Ningbo University

UNKNOWN

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

wanghongxing

Professor, MD & PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongxing Wang, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Central Contacts

Xiaolei Liu, MD & PhD

Role: CONTACT

ring@vip.163.com

+86 10 83198650

Wenfeng Zhao, MD

Role: CONTACT

fengfeng_zw@ccmu.edu.cn

+86 13051118863

References

Zhao W, Wang H, Leng H, Xue Q, Peng M, Jin X, Tan L, Pan N, Wang X, Wang J, Gao K, Zhang X, Wang H. Acute effect of twice-daily 15 mA transcranial alternating current stimulation on treatment-resistant depression: a case series study. Gen Psychiatr. 2023 Nov 10;36(6):e101278. doi: 10.1136/gpsych-2023-101278. eCollection 2023. No abstract available.

Reference Type: BACKGROUND

PMID: 38028814 (View on PubMed)

Related Links

http://pubmed.ncbi.nlm.nih.gov/38028814/

Related Info

Other Identifiers

TRD-tACS

Identifier Type: -

Identifier Source: org_study_id