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tDCS & Auditory Hallucinations in Schizophrenia

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Active tDCS

control

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring dorsolateral prefrontal cortex, left superior temporal gyrus, auditory hallucinations, transcranial direct current stimulation (tDCS)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ages 18-60
Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
Persistent auditory verbal hallucinations
Right handed
Under stable doses of antipsychotic medication for ≥4 weeks
Normal hearing by self-report and physical exam
Use of effective method of birth control for women of childbearing capacity
Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent

Exclusion Criteria:

Current or past history of substance dependence or abuse (excluding nicotine)
Other current Axis I disorders
History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
Frequent and persistent migraines
History of adverse reaction to neurostimulation
Participation in study of investigational medication within 6 weeks
Pregnancy
Women who are breast-feeding
Current significant laboratory abnormality

Sites / Locations

Herzog Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

control

Arm Description

active tDCS

sham (placebo) tDCS condition

Outcomes

Primary Outcome Measures

change from baseline in auditory hallucination rating scale

Secondary Outcome Measures

change in self-report quality of life scale from baseline

Full Information

NCT ID

NCT02227563

First Posted

May 20, 2014

Last Updated

November 1, 2016

Sponsor

Herzog Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02227563

Brief Title

tDCS & Auditory Hallucinations in Schizophrenia

Official Title

tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Terminated

Why Stopped

Lack of participants that fit inclusion criteria

Study Start Date

March 2014 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Herzog Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.

6. Conditions and Keywords

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

Schizophrenia

Keywords

dorsolateral prefrontal cortex, left superior temporal gyrus, auditory hallucinations, transcranial direct current stimulation (tDCS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Experimental

Arm Description

active tDCS

Arm Title

control

Arm Type

Sham Comparator

Arm Description

sham (placebo) tDCS condition

Intervention Type

Device

Intervention Name(s)

Active tDCS

Intervention Description

repetitive daily tDCS sessions for a period of one week

Intervention Type

Device

Intervention Name(s)

control

Primary Outcome Measure Information:

Title

change from baseline in auditory hallucination rating scale

Time Frame

1 week post-treatment

Secondary Outcome Measure Information:

Title

change in self-report quality of life scale from baseline

Time Frame

1 week post treatment

Other Pre-specified Outcome Measures:

Title

change from baseline in auditory event related potentials (ERP)

Time Frame

change in auditory ERP from baseline at 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 18-60 Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia Persistent auditory verbal hallucinations Right handed Under stable doses of antipsychotic medication for ≥4 weeks Normal hearing by self-report and physical exam Use of effective method of birth control for women of childbearing capacity Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent Exclusion Criteria: Current or past history of substance dependence or abuse (excluding nicotine) Other current Axis I disorders History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator) Frequent and persistent migraines History of adverse reaction to neurostimulation Participation in study of investigational medication within 6 weeks Pregnancy Women who are breast-feeding Current significant laboratory abnormality

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oded Meiron, PhD

Organizational Affiliation

Sarah Herzog Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herzog Hospital

City

Jerusalem

ZIP/Postal Code

9103702

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

22581236

Citation

Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum In: Am J Psychiatry. 2012 Dec 1;169(12):1321.

Results Reference

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tDCS & Auditory Hallucinations in Schizophrenia

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