tDCS & Auditory Hallucinations in Schizophrenia | NCT02227563

Studies
tDCS & Auditory Hallucinations in Schizophrenia

NCT02227563

Sponsor

Herzog Hospital

Status

Terminated

Last Update Posted

Nov 2, 2016Estimated

Enrollment

3Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Active tDCS
control

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of participants that fit inclusion criteria

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

May 20, 2014

First Submission Date that Met QC Criteria

Aug 27, 2014

First Posted Date

Aug 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active tDCS	Experimental	active tDCS	Device: Active tDCS
control	Sham Comparator	sham (placebo) tDCS condition	Device: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active tDCS	Device	repetitive daily tDCS sessions for a period of one week	Active tDCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline in auditory hallucination rating scale		1 week post-treatment

Secondary Outcomes

Measure	Description	Time Frame
change in self-report quality of life scale from baseline		1 week post treatment

Other Outcomes

Measure	Description	Time Frame
change from baseline in auditory event related potentials (ERP)		change in auditory ERP from baseline at 1 week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Oded Meiron, PhD	Sarah Herzog Memorial Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Herzog Hospital		Jerusalem	Israel	9103702	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22581236	Background	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.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations