TDCS for Auditory Hallucinations in Schizophrenia
|ClinicalTrials.gov Identifier: NCT01898299|
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Device: transcranial Direct Current Stimulation (tDCS) Device: Sham tDCS||Not Applicable|
90 patients with persistent auditory verbal hallucinations will be recruited to this study. Each individual will participate in behavioral assessments lasting up to 3 hours each and will then be randomized to receive a series of active vs. sham tDCS treatments. For active treatment, patients will have the inhibitory (cathodal) tDCS electrode placed over left auditory cortex relative to an anodal placed over frontal cortex on the right side. tDCS treatments will take place for 20 min per day for 5 consecutive days. For sham, procedures will be similar except that sham (inactive) tDCS treatment will be used. Assessment batteries will then be repeated following completion of treatment and at 1 and 3 mo following treatment. In addition, patients will be offered the possibility to participate in a concurrent magnetic resonance imaging (MRI) study aimed at evaluating the effects of tDCS on activation of auditory cortex during an auditory discrimination task as well as on other imaging parameters related to resting brain activity and metabolism. Patients who agree to participate in this MRI study will be scanned before and after active or sham tDCS. In addition, 5-15 schizophrenia patients will complete a week of High-density, e.g., "high-definition" tDCS (HD-tDCS) open label.
In addition to hallucinating patients, we will recruit up to 20 healthy controls and 20 non-hallucinating patients, who will have similar assessments to the patients, but will not receive tDCS.
Overall, the investigators hypothesize that tDCS treatment will lead to reduction in hallucinations, improvement in auditory function, and change in EEG and MRI measurements so that patients more closely resemble healthy volunteers and non-hallucinating patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||tDCS for Auditory Hallucinations in Schizophrenia|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||December 14, 2017|
|Actual Study Completion Date :||January 14, 2018|
Experimental: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) treatments will take place for 20 minutes per day for 5 consecutive days
Device: transcranial Direct Current Stimulation (tDCS)
A neurostimulation technique that passes an extremely weak electric current through the brain.
Other Name: BrainStim SYS
Sham Comparator: Sham tDCS
Sham tDCS(inactive)treatment (transcranial Direct Current Stimulation) will take place for 20 minutes per day for 5 consecutive days.
Device: Sham tDCS
Sham (inactive) tDCS treatment
- Severity of refractory auditory hallucinations [ Time Frame: Change from baseline in Auditory Hallucination Rating Scale after 5 day treatment ]Auditory hallucinations as determined by Auditory Hallucinations Rating Scale (AHRS)
- Severity of negative schizophrenia symptoms [ Time Frame: Change from baseline in Positive and Negative Symptom Scale after 5 day treatment ]Negative schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS)
- Auditory function [ Time Frame: Comparing baseline to after 5 days of treatment ]Optional outcome: Increased amplitude of the auditory steady-state response (ASSR) and N1 auditory event-related potential (ERP) component as well as increased corollary discharge modulation of the N1 auditory ERP produced when patients produce versus listen to speech and auditory word recognition task
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898299
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Nathan Kline Institute|
|Orangeburg, New York, United States, 10962|
|Principal Investigator:||Daniel C Javitt, MD||Nathan Kline Institute, New York State Psychiatric Institute|