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Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Auditory Hallucinations
Schizophrenia
Schizoaffective Disorder

Treatments

Device: tDCS
Device: Sham stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01963676
13-2995

Details and patient eligibility

About

Investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.

Full description

AIM 1: To evaluate the effect of transcranial direct current stimulation (tDCS) (2mA for 20min on five consecutive days) on auditory hallucinations in schizophrenia patients using the change in ratings on the Auditory Hallucination Rating Scale (AHRS) by patients before and after stimulation. We hypothesize that tDCS will modulate the abnormal neuronal activity found in schizophrenic patients and thereby decrease their auditory hallucinations when measured after stimulation.

AIM 2: To evaluate the long term effects of tDCS by having patients give a rating on the AHRS after one month has passed since stimulation and comparing this value to their baseline score and their score immediately after stimulation. We hypothesize that there will remain a significant reduction in auditory hallucination score in participants who received tDCS at one month.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year.
  • 18-99 years old.
  • Clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care .
  • On current antipsychotic doses for approximately 4 weeks or more.
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent) OR has a legal guardian who can complete consent forms on the patients behalf
  • Right handed

Exclusion criteria

  • Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months.
  • History of significant head injury/trauma, as defined by loss of consciousness for more than 1 hour, or recurring seizures, or requiring later cognitive rehabilitation or causing cognitive sequelae.
  • Prior brain surgery.
  • Any brain devices/implants, including cochlear implants and aneurysm clips.
  • Co-morbid neurological condition (i.e. seizure disorder, brain tumor).
  • Medical or neurological illness (unstable cardiac disease AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation.
  • Non English speakers.
  • Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

26 participants in 2 patient groups

transcranial direct current stimulation (tDCS)
Experimental group
Description:
13 subjects total. 2mA stimulation for 20 minutes.
Treatment:
Device: tDCS
Sham stimulation
Sham Comparator group
Description:
13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Treatment:
Device: Sham stimulation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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