Recruiting

tDCS

Sponsor:

University of Ottawa

Code:

NCT04222582

Conditions

Auditory Hallucination, Verbal

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Transcranial direct current stimulation (tDCS)

Study Details

Brief summary:

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.

Conditions

Auditory Hallucination, Verbal

Study ID

NCT04222582

Start date

Jan 1, 2019

Status verified date

Jan, 2020

Completion date

Jan, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Patients - 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)

Patients - 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

Healthy Controls - Inclusion Criteria:

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

Healthy Controls - Exclusion Criteria:

  • 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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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).

sham comparator: 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.

other: 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.

no intervention: 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.

Interventions

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.

Primary outcome measure

  • Change in auditory hallucination severity measured by the Psychotic Symptom Rating Scale (PSYRATS) [ Time Frame: Baseline, after 2nd tDCS session on days 1, 3, and 5, and follow-up (within a week of completing tDCS) ]

Central Contacts and Locations

Central contacts

Bronwen Schryver, B.Sc.

613 722 6521bronwen.schryver@theroyal.ca

Locations

Royal Ottawa Mental Health Centre

Recruiting

Ottawa, Ontario, Canada, K1Z7K4

Contacts

Bronwen Schryver, B.Sc.

800-987-6424bronwen.schryver@theroyal.ca

Principal Investigator:

Verner Knott, PhD, C.Psych

More Information

Sponsor

University of Ottawa

Last update posted

Jan 10, 2020

Last verified

Jan, 2020

Keywords

  • Schizophrenia
  • Transcranial direct current stimulation (tDCS)
  • Schizoaffective disorder
  • EEG
  • Brain imaging
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2020-01-10.