Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia

NCT05282329 | Completed DMC

• 1 other identifier: tACS-TJAH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the feasibility and efficacy of transcranial alternating current stimulation (tACS) as an add-on treatment for auditory hallucinations in refractory schizophrenia. Meanwhile, we aim to evaluate the effect of tACS on cognitive function of schizophrenia patients. we hypothesize tACS would improve refractory auditory hallucination symptoms in schizophrenia by regulating the gamma frequency band of temporal lobe。

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• The change over time in the score of Psychotic Symptom Rating Scales (PSYRATS)

  The main objective is to explore whether tACS combined with antipsychotics could improve refractory auditory hallucinations in schizophrenia after 4-week treatment. PSYRATS were assessed at baseline and week 2, 4, 6. Higher total score of the scale means more severe auditory hallucinations symptoms.

  baseline, week 2, week 4, week 6

Secondary Outcomes (6)

• The change over time in the score of Hamilton Depression Rating Scale (HAMD-17)

  baseline, week 2, week 4, week 6

• The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)

  baseline, week 2, week 4, week 6

• The change of scores in cognition

  baseline, week 4

• The changes of levels of Brain Derived Neurotrophic Factor in peripheral blood from baseline to week 6

  baseline, week 4, week 6

• The change of scores of Adverse events scale from baseline to week 4

  week 1, week 2, week 3, week 4

Study Arms (2)

tACS group

EXPERIMENTAL

Participants receive tACS 20-min sessions in a 5-day sequence for four consecutive weeks,combined with original and stable medication. Active group participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe.

Device: Transcranial alternating Current Stimulation (tACS)-active

Sham group

SHAM COMPARATOR

Controls received sham stimulation with the same protocol.

Device: Transcranial Alternating Current Stimulation (tACS)-sham

Interventions

Transcranial alternating Current Stimulation (tACS)-active DEVICE

Transcranial alternating current stimulation (tACS) employs a weak electric current for non-invasive brain stimulation with a sine-wave waveform, targeting brain oscillations in a frequency-specific manner. daily tACS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe.

tACS group

Transcranial Alternating Current Stimulation (tACS)-sham DEVICE

Transcranial alternating current stimulation (tACS) employs a weak electric current for non-invasive brain stimulation with a sine-wave waveform, targeting brain oscillations in a frequency-specific manner. Controls received sham stimulations with the same protocol.

Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants aged 18-70 with DSM-5-defined schizophrenia or schizophrenia-like disorder.
• Duration of illness \> 12 weeks.
• Being clinically stable and on an adequate therapeutic dose of antipsychotics for at least 8 weeks prior to enrolment.
• Junior high school education or above
• After treatment with ≥ 2 different antipsychotics (greater than the equivalent dose of chlorpromazine 600mg), the curative effect was poor (CGI ≥ 4 points or the PANSS score reduction rate since this treatment was less than 20%)
• Agreement to participate in the study and provide the written informed consent.

You may not qualify if:

• Having unstable medical conditions, current psychiatric comorbidity or active substance use disorder (in exception to caffeine and/or tobacco)
• Having Serious physical diseases or nervous system diseases;
• Having any brain device / implant, including cochlear implant and aneurysm clip;
• Having a history or family history of autoimmune diseases or immune diseases;
• Pregnancy or breastfeeding at enrollment;
• Skin lesions on scalp at the area of electrode application.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 16, 2022
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 21, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-09

Locations

CN (1)