Clinical trial NCT03485131: Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations
Official title: Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Hallucination
Schizophrenia
Lead sponsor: Manhattan Psychiatric Center
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized, parallel design
Primary purpose: TREATMENT

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 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.

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. Based on and expanding the findings by Brunelin et al. the hypothesis is that tDCS treatment with the cathode on the left temporal-parietal junction and the anode on the left dorsolateral prefrontal cortex can reduce the severity of auditory verbal hallucinations in patients with treatment refractory schizophrenia. The impact of tDCS on other schizophrenia symptoms in secondary exploratory outcome analyses together with the examination of the durability of an ameliorating effect will also be investigated.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Reduction on the severity of auditory verbal hallucinations
timeFrame: 8 weeks
Secondary outcomes:
measure: Impact of tDCS on other schizophrenia symptoms
timeFrame: 8 weeks
measure: Impact of tDCS on Clinical Global Impression
timeFrame: 8 weeks
measure: Impact of tDCS on MATRICS
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
Study officials:
affiliation: Manhattan Psychiatric Center
name: Jean-Pierre Lindenmayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5.