Back to resultstDCS to Enhance Cognitive Training in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subjects are 18 years of age or above.
- Subjects meet criteria for a DSM -IV schizophrenia or schizoaffective disorder but with a stable mental status as demonstrated by a stable Positive and Negative Symptom Score (PANSS) score over a period of 2 weeks.
- Subjects have had no medication changes in the 2 weeks prior to obtaining informed consent.
- Subjects are right-handed.
- Subjects able to give informed consent for the trial.
Exclusion Criteria:
- Drug or alcohol abuse or dependence (preceding 3 months).
- Concurrent anticonvulsant or long acting benzodiazepine medication, as these medications may interfere with the effects of tDCS.
- Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
- Clinically defined neurological disorder or insult, including history of seizures, cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥ 30 minutes.
- Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed electrode sites.
- Female subject of child bearing age, sexually active and not using reliable contraception
Sites / Locations
- Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
active tDCS and cognitive training
sham tDCD and cognitive training
Arm Description
Transcranial direct current stimulation combined with cognitive training
Sham transcranial direct current stimulation combined with cognitive training
Outcomes
Primary Outcome Measures
Progression score on cognitive training task.
Secondary Outcome Measures
Full Information
NCT ID
NCT01733602
First Posted
November 26, 2012
Last Updated
August 7, 2017
Sponsor
The University of New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT01733602
Brief Title
tDCS to Enhance Cognitive Training in Schizophrenia
Official Title
Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
4. Oversight
5. Study Description
Brief Summary
The primary aim for the study is to determine whether transcranial direct current stimulation (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to determine whether tDCS combined with CT causes larger transferable improvements on non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are maintained over time (i.e., maintenance effects).
Specific hypotheses are:
CT combined with active tDCS will produce greater training gains on CT tasks compared to a similar control group receiving CT with sham tDCS.
CT combined with active tDCS will produce greater generalisation effects on non-trained cognitive tasks compared to CT with sham tDCS.
The cognitive improvements gained by patients from both interventions will be maintained over 1 month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS and cognitive training
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation combined with cognitive training
Arm Title
sham tDCD and cognitive training
Arm Type
Active Comparator
Arm Description
Sham transcranial direct current stimulation combined with cognitive training
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Progression score on cognitive training task.
Time Frame
Post treatment
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:
Subjects are 18 years of age or above.
Subjects meet criteria for a DSM -IV schizophrenia or schizoaffective disorder but with a stable mental status as demonstrated by a stable Positive and Negative Symptom Score (PANSS) score over a period of 2 weeks.
Subjects have had no medication changes in the 2 weeks prior to obtaining informed consent.
Subjects are right-handed.
Subjects able to give informed consent for the trial.
Exclusion Criteria:
Drug or alcohol abuse or dependence (preceding 3 months).
Concurrent anticonvulsant or long acting benzodiazepine medication, as these medications may interfere with the effects of tDCS.
Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
Clinically defined neurological disorder or insult, including history of seizures, cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥ 30 minutes.
Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed electrode sites.
Female subject of child bearing age, sexually active and not using reliable contraception
Facility Information:
Facility Name
Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2229
Country
Australia
12. IPD Sharing Statement
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tDCS to Enhance Cognitive Training in Schizophrenia
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