Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations

Completed · Not applicable · Has a placebo group

Conditions studied: Auditory Hallucination, Schizophrenia

In brief

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 will receive either 20 minutes of active tDCS (transcranial direct-current stimulation) or sham stimulation twice a day on 5 consecutive weekdays for 4 weeks with a 4 week follow-up period.

Key facts

Study ID

NCT03485131

Run by

Manhattan Psychiatric Center

People needed

27

Starts

2014-04-01

Expected to finish

2018-03-01

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Manhattan Psychiatric Center — New York, New York, United States

Full record on ClinicalTrials.gov

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