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

NCT03485131 | Completed DMC FDA Device

• 1 other identifier: 1409
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Hallucination; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Reduction on the severity of auditory verbal hallucinations

  Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items)

  8 weeks

Secondary Outcomes (3)

• Impact of tDCS on other schizophrenia symptoms

  8 weeks

• Impact of tDCS on Clinical Global Impression

  8 weeks

• Impact of tDCS on MATRICS

  8 weeks

Study Arms (2)

Transcranial direct-current stimulation

EXPERIMENTAL

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)

Sham tDCS

SHAM COMPARATOR

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

Interventions

Transcranial direct-current stimulation (tDCS) DEVICE

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

Also known as: Active Transcranial direct-current stimulation (tDCS)'

Transcranial direct-current stimulation

Placebo DEVICE

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

Also known as: Sham Transcranial direct-current stimulation (tDCS)

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Manhattan Psychiatric Center: lead

Study Sites (1)

Manhattan Psychiatric Center

New York, New York, 10035, United States

Location

Related 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.

  PMID: 19348793 RESULT

MeSH Terms

Conditions

Hallucinations; Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jean-Pierre Lindenmayer, MD

  Manhattan Psychiatric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Raters were blind as was PI.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Two group randomized, parallel design

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: April 2, 2018
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)