tDCS to Enhance Cognitive Training in Schizophrenia

This study is currently recruiting participants.
Verified November 2012 by The University of New South Wales
Sponsor:
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01733602
First received: November 26, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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:

  1. CT combined with active tDCS will produce greater training gains on CT tasks compared to a similar control group receiving CT with sham tDCS.
  2. CT combined with active tDCS will produce greater generalisation effects on non-trained cognitive tasks compared to CT with sham tDCS.
  3. The cognitive improvements gained by patients from both interventions will be maintained over 1 month follow-up.

Condition Intervention Phase
Schizophrenia
Device: transcranial direct current stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Progression score on cognitive training task.

Estimated Enrollment: 52
Study Start Date: November 2012
Arms Assigned Interventions
Experimental: active tDCS and cognitive training Device: transcranial direct current stimulation
Active Comparator: sham tDCD and cognitive training Device: transcranial direct current stimulation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects are 18 years of age or above.
  2. 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.
  3. Subjects have had no medication changes in the 2 weeks prior to obtaining informed consent.
  4. Subjects are right-handed.
  5. Subjects able to give informed consent for the trial.

Exclusion Criteria:

  1. Drug or alcohol abuse or dependence (preceding 3 months).
  2. Concurrent anticonvulsant or long acting benzodiazepine medication, as these medications may interfere with the effects of tDCS.
  3. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  4. Clinically defined neurological disorder or insult, including history of seizures, cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥ 30 minutes.
  5. Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed electrode sites.
  6. Female subject of child bearing age, sexually active and not using reliable contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733602

Contacts
Contact: Aparna Menon, MD 61 2 9540 8232 AparnaMenon.TarurPadinjareveet@sesiahs.health.nsw.gov.au

Locations
Australia, New South Wales
Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital Recruiting
Sydney, New South Wales, Australia, 2229
Contact: Aparna Menon, MD    61 2 9540 8232    AparnaMenon.TarurPadinjareveet@sesiahs.health.nsw.gov.au   
Principal Investigator: Aparna Menon, MD         
Sponsors and Collaborators
The University of New South Wales
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01733602     History of Changes
Other Study ID Numbers: 11/188
Study First Received: November 26, 2012
Last Updated: November 26, 2012
Health Authority: Therapeutic Goods Administration: Australia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014