Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder

NCT05286645 | Completed

• 1 other identifier: AHMU-tdcs-depression
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI.

Conditions

Transcranial Direct Current Stimulation; Functional Magnetic Resonance Imaging; Depressive Disorder

Keywords

Transcranial Direct Current Stimulation; Functional Magnetic Resonance Imagin; Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• the change of somatic symptoms in active group and sham group at post-treatment and follow-up visit.

  the somatic symptoms were assessed by PHQ-15 scale.

  Baseline, Week 2 and Week 8.

• the percentage decrease in PHQ-15 scores in active group and sham group at post-treatment and follow-up visit.

  The percentage of decrease in scores was measured using the following formula: (pretreatment scores - post-treatment scores)/pretreatment scores × 100 %).

  Baseline, Week 2 and Week 8.

• the number of somatic responders in active group and sham group at post-treatment and follow-up visit.

  Responders were defined as patients who had a ≥ 50% decrease in the PHQ-15 score.

  Baseline, Week 2 and Week 8.

Secondary Outcomes (3)

• the change of depressive symptoms in active group and sham group at post-treatment and follow-up visit.

  Baseline, Week 2 and Week 8.

• the percentage decrease in HAMD scores in active group and sham group at post-treatment and follow-up visit.

  Baseline, Week 2 and Week 8.

• the number of depressive responders in active group and sham group at post-treatment and follow-up visit.

  Baseline, Week 2 and Week 8.

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

Participants will receive active tDCS once daily for two weeks. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions.

Device: High definition transcranial direct current stimulation

sham stimulation

PLACEBO COMPARATOR

Participants will receive sham tDCS once daily for two weeks. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Device: sham high definition transcranial direct current stimulation

Interventions

High definition transcranial direct current stimulation DEVICE

tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes.

real stimulation

sham high definition transcranial direct current stimulation DEVICE

Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

sham stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD\>17, PHQ-15\>5.
• the age ranged from 18 to 60 years old
• right-handed
• stable dose of medication for at least 4 weeks or no history of antidepressive drugs before intervention

You may not qualify if:

• accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
• accompanied by other neurological diseases, such as stroke, epilepsy and so on.
• accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.
• patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.
• pregnancy and breastfeeding.
• previous physical treatment (electroconvulsive therapy or tDCS).

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, China

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Ting Zhang

  Anhui Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical psychological department, Anhui Medical University

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: March 18, 2022
• Study Start: January 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 12, 2026

Record last verified: 2024-09

Locations

CN (1)