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tDCS to Enhance Cognitive Training in Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by The University of New South Wales.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Melissa Pigot, The University of New South Wales Identifier:
First received: November 26, 2012
Last updated: August 11, 2014
Last verified: August 2014

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
Device: transcranial direct current stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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. [ Time Frame: Post treatment ]

Estimated Enrollment: 52
Study Start Date: November 2012
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active tDCS and cognitive training
Transcranial direct current stimulation combined with cognitive training
Device: transcranial direct current stimulation
Active Comparator: sham tDCD and cognitive training
Sham transcranial direct current stimulation combined with cognitive training
Device: transcranial direct current stimulation


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01733602

Contact: Aparna Menon, MD 61 2 9540 8232

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   
Principal Investigator: Aparna Menon, MD         
Sponsors and Collaborators
The University of New South Wales
  More Information

Responsible Party: Melissa Pigot, Research Assistant, The University of New South Wales Identifier: NCT01733602     History of Changes
Other Study ID Numbers: 11/188
Study First Received: November 26, 2012
Last Updated: August 11, 2014

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on May 23, 2017