NCT02227563

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

May 20, 2014

Last Update Submit

November 1, 2016

Conditions

Schizophrenia

Keywords

dorsolateral prefrontal cortexleft superior temporal gyrusauditory hallucinationstranscranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

  • change from baseline in auditory hallucination rating scale

    1 week post-treatment

Secondary Outcomes (1)

  • change in self-report quality of life scale from baseline

    1 week post treatment

Other Outcomes (1)

  • change from baseline in auditory event related potentials (ERP)

    change in auditory ERP from baseline at 1 week

Study Arms (2)

Active tDCS

EXPERIMENTAL

active tDCS

Device: Active tDCS

control

SHAM COMPARATOR

sham (placebo) tDCS condition

Device: control

Interventions

Active tDCSDEVICE

repetitive daily tDCS sessions for a period of one week

Active tDCS
controlDEVICE
control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzog Hospital

Jerusalem, Israel, 9103702, Israel

Location

Related Publications (1)

  • 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.

    PMID: 22581236BACKGROUND

MeSH Terms

Conditions

SchizophreniaHallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oded Meiron, PhD

    Sarah Herzog Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

August 28, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-08

Locations

IL(1)