NCT01607840

Brief Summary

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities and alter functional connectivity in individuals with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Participants also receive a brain scan before and after stimulation. Our aim is to determine if tDCS can improve mental abilities in individuals with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

May 24, 2012

Last Update Submit

August 31, 2015

Conditions

Keywords

SchizophreniaCognitive ImprovementtDCSstimulation

Outcome Measures

Primary Outcomes (1)

  • Cognitive Test Performance

    Cognitive test performance by subjects will be evaluated upon completion of enrollment to determine if tDCS improved performance on cognitive tests.

    The average time frame is approximately 2 hours

Secondary Outcomes (1)

  • Functional Connectivity Changes Associated with tDCS

    Time frame is approximately 2 hours

Study Arms (3)

Anodal Stimulation

EXPERIMENTAL

transcranial direct current stimulation using Anodal stimulation over the area of interest

Procedure: transcranial direct current stimulation

Cathodal

EXPERIMENTAL

transcranial direct current stimulation using cathodal stimulation over the brain area of interest

Procedure: transcranial direct current stimulation

Sham Stimulation

SHAM COMPARATOR

transcranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without actually delivering tDCS

Procedure: transcranial direct current stimulation

Interventions

delivery of transcranial direct current stimulation or sham for 20 to 60 minutes

Anodal StimulationCathodalSham Stimulation

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Schizophrenia
  • English as a native language

You may not qualify if:

  • appreciable deficits in hearing or vision
  • appreciable accent
  • any implanted metal device or pacemaker
  • Dementia or Mini Mental Exam below 24
  • History of Seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Barry Gordon

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Editor-in-Chief, Cognitive and Behavioral Neurology/Therapeutic Cognitive Neuroscience Professor/Professor of Neurology and Cognitive Science

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 30, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations