NCT02823639

Brief Summary

Impairments of cognition are a core, severely disabling feature of schizophrenia leading to poor long-term outcome with no established treatment available. Particularly impaired executive functions (e.g working memory) are frequently observed and are consistently associated with reduced activation of the dorsolateral prefrontal cortex (dlPFC). Deficits in those functions have been shown to be closely related to negative symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion that frontal lobe dysfunction is crucially important in schizophrenic psychopathology. Noninvasive brain stimulation like tDCS can enhance executive functions like working memory in healthy subjects as well as in patients. To identify the optimal parameters for this intervention in patients with schizophrenia, the investigators first test the effects of different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality (left, right) on working-memory performance (nback task) in a sham-controlled cross-over design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be registered with electroencephalography (EEG). These experiments will provide reliable data for an evidence-based development of new clinical interventions to improve treatment of cognitive deficits in patients with schizophrenia and thus enhance schizophrenia prevention and recovery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

6.8 years

First QC Date

June 20, 2016

Last Update Submit

April 27, 2021

Conditions

Anodal Stimulation tDCSSchizophreniaWorking Memory

Outcome Measures

Primary Outcomes (1)

  • Change of dprime

    dprime provides the separation between the means of the signal and the noise distributions, compared against the standard deviation of the signal plus noise distributions

    Assessment during stimulation in a n-back task at three specific timepoints during one week

Secondary Outcomes (1)

  • Change of reaction time in n-back task

    Assessment during stimulation in a n-back task at three specific timepoints during one week

Study Arms (2)

Transcranial direct current stimulation

ACTIVE COMPARATOR

tDCS with varying intensity, location and polarity

Procedure: Transcranial direct current stimulation

Sham stimulation

PLACEBO COMPARATOR

Double blind sham stimulation with sham mode of neuroConn device

Procedure: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationPROCEDURE
Also known as: tDCS
Sham stimulationTranscranial direct current stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed schizophrenia (DSM-V)
  • age (18 - 60 years)
  • right handedness
  • stable medication during 1 week of treatment and 1 week before

You may not qualify if:

  • history of seizures
  • metal device throughout the body
  • pregnancy
  • use of anticonvulsive medication
  • use of benzodiazepines more than 1 mg of Lorazepam equivalent
  • current substance abuse (nicotine excluded)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LMU Muenchen, Department of Psychiatry and Psychotherapy

München, Germany

RECRUITING

University Hospital Tuebigen, Department of Psychiatry and Psychotherapy

Tübingen, 72076, Germany

RECRUITING

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 Officials

  • Christian Plewnia, Prof., MD

    University Hospital Tuebingen, Department of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Plewnia, MD

CONTACT

++49 (0)7071-2986121christian.plewnia@uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 6, 2016

Study Start

October 1, 2015

Primary Completion

August 1, 2022

Study Completion

October 1, 2022

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

DE(2)