Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucinations in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Many individuals with schizophrenia struggle with auditory verbal hallucinations (AVHs). In some cases, these AVHs can be resistant to medication treatment. Previous research has found that transcranial direct current stimulation (tDCS) can be helpful in treating symptoms in individuals with other psychiatric disorders, such as depression. This study will assess if tDCS is effective in treating AVHs in individuals with schizophrenia. tDCS is a non-invasive form of brain stimulation which uses a weak current to temporarily excite or inhibit underlying cortical regions with small electrodes placed on the scalp. tDCS has been found to improve mental processes, including attention and memory function. In addition to examining the effect of tDCS on AVHs, this study will assess the effects of tDCS on mood as well as brain electrical activity with electroencephalogram (EEG) recordings. As an additional component, participants will be invited to participate in neuroimaging. Using magnetic resonance imaging (MRI), brain activity and structure will be examined before and after tDCS. tDCS will be administered twice daily for 5 consecutive days for a total of 10 sessions. These study findings will contribute to the understanding of the impact of tDCS on AVHs, and will also increase knowledge of sound and memory/cognitive processing in individuals with schizophrenia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

STimulation to Improve Auditory haLLucinations

NCT02360228

Schizophrenia Schizoaffective Disorder

COMPLETED NA

Targeting Auditory Hallucinations With Alternating Current Stimulation

NCT03221270

Schizophrenia Schizo Affective Disorder

COMPLETED NA

Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations

NCT03485131

Auditory Hallucination Schizophrenia

COMPLETED NA

Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

NCT00870909

Schizophrenia Auditory Hallucinations

COMPLETED NA

The Effects of tDCS on Illness Awareness in Schizophrenia

NCT02848885

Schizophrenia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Auditory Hallucination, Verbal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active tDCS

Administration of a 2 milliamp (mA) current delivered via two scalp electrodes for 20 minutes (ramp-in + ramp-out periods, 30s total) 2 times per day for 5 consecutive days, \>3 hour interval between sessions, for a total of 10 tDCS sessions.

tDCS will be administered with a constant current regulator (NeuroConn DC-Stimulator Plus®, Germany) using 2 saline-soaked sponge electrodes applied over the scalp. Using the 10-20 international EEG system for tDCS electrode placement, the anode will be positioned midway between F3 and Fp1 (left DLPFC) and the cathode midway between T3 and P3 (left TPJ).

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a weak current (2mA direct current) to temporarily excite or inhibit underlying brain regions with small electrodes placed on the scalp.

Sham tDCS

Administration of 2mA tDCS for 30 seconds followed by 19.5 minutes of no current via two scalp electrodes for 20 min (2X/day for 5 consecutive days) with \>3 hours interval between sessions, for a total of 10 tDCS sessions.

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a weak current (2mA direct current) to temporarily excite or inhibit underlying brain regions with small electrodes placed on the scalp.

Open-label Active tDCS

Subjects who have received sham tDCS will be given the option to subsequently receive 10 sessions of open-label active tDCS (2X/day for 5 consecutive days) with \>3 hours interval between sessions, for a total of 10 tDCS sessions.

Group Type OTHER

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a weak current (2mA direct current) to temporarily excite or inhibit underlying brain regions with small electrodes placed on the scalp.

Healthy Control

Healthy volunteers will complete the same questionnaires, EEG recording procedures, and neuroimaging scans as the schizophrenia patient group, but will not undergo tDCS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a weak current (2mA direct current) to temporarily excite or inhibit underlying brain regions with small electrodes placed on the scalp.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary diagnosis of schizophrenia or schizoaffective disorder
* Clinically stable (discretion of psychiatrist)
* Consistent history of AVHs over the course of illness
* \>3 AVHs per week
* Positive and Negative Syndrome Scale (PANSS) score of \>3
* Primary medications limited to one of the atypical antipsychotics (medications stabilized for 4 weeks prior to enrollment)

* In good physical health
* No history of serious mental health issues

Exclusion Criteria

* Experiencing an acute psychotic episode
* Current drug/alcohol dependence
* Significant medical illness \& mental retardation/learning disability
* Extra-pyramidal symptoms resulting in disordered movement
* Abnormal audiometric assessment (thresholds for pure tones \>25 dB)
* History of significant neurological issues \& head injuries/concussions resulting in loss of consciousness for \>5 minutes

* Personal history of psychiatric disorder
* Family history of schizophrenia in first degree relatives \& history of mental health issues in first degree relatives that required extensive treatment or hospitalization
* Current/history of substance abuse
* Significant medical illness
* Extra-pyramidal symptoms resulting in movement disorder
* Abnormal audiometric assessment (thresholds for pure tones \>25 dB)
* Significant neurological issues \& head injuries/concussions resulting in loss of consciousness for \>5 minutes

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes