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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Auditory Hallucination
• Intervention / Treatment: Device: Transcranial direct-current stimulation (tDCS); Device: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10035
      • Manhattan Psychiatric Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transcranial direct-current stimulation; Intervention of 2 mAmp Transcranial direct-current stimulation treatments given twice daily for 20 min each per day for 4 weeks on consecutive weekdays. Twice-daily sessions were separated by at least 3 hours (one in the AM and the other one in the PM)	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; Other Names: Active Transcranial direct-current stimulation (tDCS)'
SHAM_COMPARATOR: Sham tDCS; Intervention of placebo stimulation with ranscranial direct-current stimulation(sham tDCS), the stimulation parameters were displayed, but after 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse was delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period	Device: 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; Other Names: Sham Transcranial direct-current stimulation (tDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction on the severity of auditory verbal hallucinations	Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of tDCS on other schizophrenia symptoms	Reduction of scores in Positive and Negative Symptom Scale	8 weeks
Impact of tDCS on Clinical Global Impression	Global Severity of Illness measure	8 weeks
Impact of tDCS on MATRICS	MATRICS: Comprehensive assessment of cognitive functions	8 weeks

Collaborators and Investigators

• Sponsor: Manhattan Psychiatric Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (ACTUAL): April 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Hallucinations
• Other Study ID Numbers: 1409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes