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

Schizophrenia Clinical Trial

— tDCS  

Official title:

Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485131
• Other study ID #: 1409
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: April 2, 2018
• Start date: April 2014
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Manhattan Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Hallucination
• Hallucinations
• Schizophrenia

Intervention

Device:
• Transcranial direct-current stimulation (tDCS)
Stimulation sessions will be conducted twice a day on 5 consecutive weekdays. The twice daily sessions will be separated by at least 3 hours (one in the morning and the other one in the PM). The duration of treatment will be 4 weeks
• Placebo
Placebo/sham stimulation: After 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse is delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period

Locations

Country	Name	City	State
United States	Manhattan Psychiatric Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Manhattan Psychiatric Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction on the severity of auditory verbal hallucinations	Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items)	8 weeks
Secondary	Impact of tDCS on other schizophrenia symptoms	Reduction of scores in Positive and Negative Symptom Scale	8 weeks
Secondary	Impact of tDCS on Clinical Global Impression	Global Severity of Illness measure	8 weeks
Secondary	Impact of tDCS on MATRICS	MATRICS: Comprehensive assessment of cognitive functions	8 weeks