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OpenTrials
Completed

NCT Number: NCT01733602

tDCS to Enhance Cognitive Training in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital

Sydney, New South Wales, 2229, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Primary outcomes

  1. Progression score on cognitive training task.

    Time frame: Post treatment

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Official study title

Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?

Important dates

Study start
2012
Primary completion
2016
First posted
Nov 27, 2012
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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