Open-label Active tDCS for Verbal Auditory Hallucinations

N/A

Waitlist Available

Led By Verner Knott, PhD, C.Psych

Research Sponsored by University of Ottawa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 2nd tdcs session on days 1, 3, and 5, and follow-up (within a week of completing tdcs)

Summary

This trial will assess whether transcranial direct current stimulation (tDCS) is an effective treatment for auditory verbal hallucinations (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.

Eligible Conditions

Verbal Auditory Hallucinations

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 2nd tdcs session on days 1, 3, and 5, and follow-up (within a week of completing tdcs)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 2nd tdcs session on days 1, 3, and 5, and follow-up (within a week of completing tdcs)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 2nd tdcs session on days 1, 3, and 5, and follow-up (within a week of completing tdcs) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS)

Secondary study objectives

Change in Beliefs about Voices Questionnaire-Revised (BAVQ-R) Scores

Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Mismatch Negativity (tonal)

Change in Brain Functional Magnetic Resonance Imaging (fMRI) - Resting-State

+12 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Open-label Active tDCSExperimental Treatment1 Intervention

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 II: Active tDCSActive Control1 Intervention

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 III: Healthy ControlActive Control1 Intervention

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

Group IV: Sham tDCSPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial direct current stimulation (tDCS)

2016

Completed Phase 3

~870

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