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

Primary Purpose

Auditory Hallucination, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct-current stimulation (tDCS)
Placebo
Sponsored by
Manhattan Psychiatric Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Auditory Hallucination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manhattan Psychiatric Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial direct-current stimulation

Sham tDCS

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Reduction on the severity of auditory verbal hallucinations
Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items)

Secondary Outcome Measures

Impact of tDCS on other schizophrenia symptoms
Reduction of scores in Positive and Negative Symptom Scale
Impact of tDCS on Clinical Global Impression
Global Severity of Illness measure
Impact of tDCS on MATRICS
MATRICS: Comprehensive assessment of cognitive functions

Full Information

First Posted
March 1, 2016
Last Updated
April 2, 2018
Sponsor
Manhattan Psychiatric Center
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1. Study Identification

Unique Protocol Identification Number
NCT03485131
Brief Title
Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations
Acronym
tDCS
Official Title
Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manhattan Psychiatric Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Hallucination, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group randomized, parallel design
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Raters were blind as was PI.
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial direct-current stimulation
Arm Type
Experimental
Arm Description
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)
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial direct-current stimulation (tDCS)
Other Intervention Name(s)
Active Transcranial direct-current stimulation (tDCS)'
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sham Transcranial direct-current stimulation (tDCS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction on the severity of auditory verbal hallucinations
Description
Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Impact of tDCS on other schizophrenia symptoms
Description
Reduction of scores in Positive and Negative Symptom Scale
Time Frame
8 weeks
Title
Impact of tDCS on Clinical Global Impression
Description
Global Severity of Illness measure
Time Frame
8 weeks
Title
Impact of tDCS on MATRICS
Description
MATRICS: Comprehensive assessment of cognitive functions
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Lindenmayer, MD
Organizational Affiliation
Manhattan Psychiatric Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19348793
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.
Results Reference
result

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

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