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tDCS to Enhance Cognitive Training in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01733602
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Melissa Pigot, The University of New South Wales

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:

  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 or disease Intervention/treatment Phase
Schizophrenia Device: transcranial direct current stimulation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?
Study Start Date : November 2012
Actual Primary Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Progression score on cognitive training task. [ Time Frame: Post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733602


Locations
Australia, New South Wales
Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital
Sydney, New South Wales, Australia, 2229
Sponsors and Collaborators
The University of New South Wales

Responsible Party: Melissa Pigot, Research Assistant, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01733602     History of Changes
Other Study ID Numbers: 11/188
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders