NCT01733602

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

November 26, 2012

Last Update Submit

August 7, 2017

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Progression score on cognitive training task.

    Post treatment

Study Arms (2)

active tDCS and cognitive training

EXPERIMENTAL

Transcranial direct current stimulation combined with cognitive training

Device: transcranial direct current stimulation

sham tDCD and cognitive training

ACTIVE COMPARATOR

Sham transcranial direct current stimulation combined with cognitive training

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulationDEVICE
active tDCS and cognitive trainingsham tDCD and cognitive training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital

Sydney, New South Wales, 2229, Australia

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 27, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

AU(1)