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Non-invasive Brain Stimulation

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)
Awards & highlights

Study 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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS)
Secondary outcome measures
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
~820

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreOTHER
18 Previous Clinical Trials
2,012 Total Patients Enrolled
University of OttawaLead Sponsor
205 Previous Clinical Trials
266,007 Total Patients Enrolled
Verner Knott, PhD, C.PsychPrincipal InvestigatorUniversity of Ottawa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucinations in Schizophrenia
Dr. Verner Knott 2019. "Effects of Transcranial Direct Current Stimulation (tDCS) on Persistent Auditory Verbal Hallucinations in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04222582.
All > Tdcs
~13 spots leftby Apr 2025
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