tDCS to Enhance Cognitive Training in Schizophrenia

NCT ID: NCT01733602

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active tDCS and cognitive training

Transcranial direct current stimulation combined with cognitive training

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

sham tDCD and cognitive training

Sham transcranial direct current stimulation combined with cognitive training

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

Interventions

transcranial direct current stimulation

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

Melissa Pigot

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

11/188

Identifier Type: -

Identifier Source: org_study_id