Back to resultsTranscranial Alternating Current Stimulation (tACS) for Auditory Hallucinations
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tACS for auditory hallucinations via single arm
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- Shanghai Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
schizophrenia patients with auditory hallucinations
Arm Description
For schizophrenia patients with auditory hallucinations, tACS for implementation intervention
Outcomes
Primary Outcome Measures
Evaluation of Auditory Hallucination Scale(the minimum is 0, maximum value is 47, and higher scores mean a worse outcome)
Reduction rate of AHRS scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05159336
First Posted
November 10, 2021
Last Updated
December 2, 2021
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT05159336
Brief Title
Transcranial Alternating Current Stimulation (tACS) for Auditory Hallucinations
Official Title
Intervention Treatment of Auditory Hallucination by Transcranial Alternating Current Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
May 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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 5*5 cm electrodes. A 5* 7 cm return electrode was centered on Cz. In total, 20 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
schizophrenia patients with auditory hallucinations
Arm Type
Experimental
Arm Description
For schizophrenia patients with auditory hallucinations, tACS for implementation intervention
Intervention Type
Device
Intervention Name(s)
tACS for auditory hallucinations via single arm
Intervention Description
a 20 weeks, weekly 40 minutes, 1mA, 10Hz-tACS protocol
Primary Outcome Measure Information:
Title
Evaluation of Auditory Hallucination Scale(the minimum is 0, maximum value is 47, and higher scores mean a worse outcome)
Description
Reduction rate of AHRS scale
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yegang Hu, Doctor
Phone
021-52219305
Email
yeganghu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yegang Hu, Doctor
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yegang Hu, Doctor
Phone
021-52219305
Email
yeganghu@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33515747
Citation
Force RB, Riddle J, Jarskog LF, Frohlich F. A case study of the feasibility of weekly tACS for the treatment of auditory hallucinations in schizophrenia. Brain Stimul. 2021 Mar-Apr;14(2):361-363. doi: 10.1016/j.brs.2021.01.014. Epub 2021 Jan 27. No abstract available.
Results Reference
result
PubMed Identifier
30367952
Citation
Ahn S, Mellin JM, Alagapan S, Alexander ML, Gilmore JH, Jarskog LF, Frohlich F. Targeting reduced neural oscillations in patients with schizophrenia by transcranial alternating current stimulation. Neuroimage. 2019 Feb 1;186:126-136. doi: 10.1016/j.neuroimage.2018.10.056. Epub 2018 Oct 24.
Results Reference
result
Learn more about this trial
Transcranial Alternating Current Stimulation (tACS) for Auditory Hallucinations
We'll reach out to this number within 24 hrs