Status:
COMPLETED
Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations
Lead Sponsor:
Manhattan Psychiatric Center
Conditions:
Auditory Hallucination
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each eligible subject ...
Detailed Description
The aim in this study is to conduct a pilot study on the efficacy of tDCS by assessing its efficacy in treatment refractory auditory verbal hallucinations in inpatients with chronic schizophrenia. Bas...
Eligibility Criteria
Inclusion
- Inpatient adults (age 18-65 years) who meet diagnostic criteria for schizophrenia or schizoaffective disorder (using the Structured Clinical Interview for DSM)
- Auditory hallucinations without remission over 5 years (remission is defined as a period of 4 weeks without hallucinations) as documented in the patients' medical record
- Failure to respond to two previous adequate antipsychotic trials with adequate duration and adequate dosage
- Screening PANSS total rating of \> 70
- PANSS hallucinatory behavior item \> 4
- Capacity and willingness to sign informed consent
- On a stable antipsychotic regimen 4 weeks prior to screening and for the duration of the trial
- Normal hearing
- If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an interuterine device (IUD) which was implanted at least 2 months prior to screening, or "double-barrier" contraception
- Willing to wear the tDCS device.
Exclusion
- Prior history of seizure, other than that induced by Electro Convulsive Therapy
- Family history of seizures
- Significant unstable medical condition
- Pregnancy or women of childbearing capacity not using a medically accepted form of contraception when engaged in sexual intercourse
- Inability to provide informed consent
- Actively suicidal and or showing violent behavior
- Significant organic brain pathology by history and neurological examination, inclusive of history of head trauma, loss of consciousness for more than 5 minutes; intracranial metal implants, known structural brain lesion, devices that may be affected by transcranial Direct Current Stimulation (tDCS) (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Active substance abuse
- Increased intracranial pressure, unstable cardiovascular disease, sleep apnea
- Individuals with a clinically defined neurological disorder
- Frequent and persistent migraines
- History of adverse reaction to neurostimulation or open skin wounds that would preclude safe placement of tDCS electrodes
- Current use of medications known to lower seizure threshold (serotonergic or tricyclic antidepressants)
- If pregnant or breast feeding at the time of screening
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03485131
Start Date
April 1 2014
End Date
March 1 2018
Last Update
April 4 2018
Active Locations (1)
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1
Manhattan Psychiatric Center
New York, New York, United States, 10035