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Completed

NCT Number: NCT01963676

Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Auditory Hallucinations Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, Outpatient STEP Clinic, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

Sham stimulation

Device

Primary outcomes

  1. Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5

    Time frame: Baseline, Day 5

    Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.

Secondary outcomes

  1. Persistence of Decrease in AHRS Score Over Time

    Time frame: Day 5, One month

    We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Clinical Trial to Assess Transcranial Current Stimulation as a Treatment for Medication Refractory Auditory Hallucinations in Schizophrenia

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 16, 2013
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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