Transcranial Alternating Current Stimulation (tACS) for Auditory Hallucinations

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05159336

Collaborator

(none)

Enrollment

Location

Arm

18.3

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Transcranial alternating current stimulation (tACS) can modulate and restore neural oscillations that are reduced in patients with psychiatric illnesses such as schizophrenia. Here, we performed a open-lable study of clinical trial in 30 schizophrenia patients with auditory hallucinations to show that tACS is effective for auditory hallucinations.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: tACS for auditory hallucinations via single arm	N/A

Detailed Description

Each week, the patient rested quietly with her eyes open while receiving alpha-frequency tACS for 40 minutes. Stimulation was delivered at 10 Hz with 1 mA zero-to-peak amplitude in-phase to the location 1 and the location 2 acquired by the MEG technique with 55 cm electrodes. A 5 7 cm return electrode was centered on Cz. In total, 20 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intervention Treatment of Auditory Hallucination by Transcranial Alternating Current Stimulation

Actual Study Start Date :

Nov 16, 2021

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

May 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: schizophrenia patients with auditory hallucinations For schizophrenia patients with auditory hallucinations, tACS for implementation intervention	Device: tACS for auditory hallucinations via single arm a 20 weeks, weekly 40 minutes, 1mA, 10Hz-tACS protocol

Arm

Intervention/Treatment

Experimental: schizophrenia patients with auditory hallucinations

For schizophrenia patients with auditory hallucinations, tACS for implementation intervention

Device: tACS for auditory hallucinations via single arm

a 20 weeks, weekly 40 minutes, 1mA, 10Hz-tACS protocol

Outcome Measures

Primary Outcome Measures

Evaluation of Auditory Hallucination Scale(the minimum is 0, maximum value is 47, and higher scores mean a worse outcome) [One month]
Reduction rate of AHRS scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Schizophrenia with auditory hallucinations was diagnosed by DSM-IV, AHRS >12, Take sufficient antipsychotics for at least 1 month.

Exclusion Criteria:

current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Mental Health Center	Shanghai		China	021

Sponsors and Collaborators

Shanghai Mental Health Center

Investigators

Principal Investigator: Yegang Hu, Doctor, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Mental Health Center

ClinicalTrials.gov Identifier:

NCT05159336

Other Study ID Numbers:

NDYX20211101

First Posted:

Dec 16, 2021

Last Update Posted:

Dec 16, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hallucinations

Schizophrenia

Study Results

No Results Posted as of Dec 16, 2021