Clinical trial NCT04184830: Improving Cognition in Schizophrenia Using Non-invasive Brain Stimulation
Official title: A Pilot Study of Improving Cognition in Schizophrenia Using Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind sham-controlled study to evaluate the effects of the combination of non-invasive brain stimulation, i.e. transcranial direct current stimulation (tDCS), with brief cognitive training (CT) on cognition in patients with schizophrenia. All participants will practice the same cognitive training tasks and will be randomised to either real tDCS or sham stimulation. Patients with schizophrenia will undergo the study interventions while maintaining their standard treatment with antipsychotic medications.


Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Treatment with stable doses of antipsychotic medications. For the purpose of this study stability is defined as a not more than 50% change in the dose of their antipsychotic medication 3 months preceding the screening visit.
* Age between 18 and 55 years
* Written and witnessed informed consent
* Participants must read and write in English at a level sufficient to understand and complete study-related procedures

Exclusion Criteria:

DSM-IV diagnosis of alcohol or drug dependence in the 6 months, current treatment with benzodiazepines or hypnotics

* Current or past skin disease
* History of a neurological disorder or a systemic illness with known neurological complications; including epilepsy
* History of seizures
* Head injury, accompanied with loss of consciousness or/and required hospitalization
* Unwillingness or inability to follow or comply with the procedures outlined in the protocol

Primary outcomes:
measure: Does the combination of tDCS with brief working memory training will enhance the learning capacity of the research participants compared to sham stimulation, and whether the learning rates will be retained in the longer-term
timeFrame: 56 days
measure: Does the combination of tDCS with brief stochastic learning training will enhance the learning capacity of the research participants compared to sham stimulation, and whether the learning rates will be retained in the longer-term
timeFrame: 56 days
measure: Does the combination of tDCS with brief implicit learning training will enhance the learning capacity of the research participants compared to sham stimulation, and whether the learning rates will be retained in the longer-term
timeFrame: 56 days
measure: The change in neuronal activity during a working memory task in response to real tDCS vs sham stimulation.
timeFrame: 1 day
measure: The change in neuronal activity during a stochastic learning task in response to real tDCS vs sham stimulation.
timeFrame: 1 day
measure: The change in neuronal activity during an implicit learning task in response to real tDCS vs sham stimulation.
timeFrame: 1 day
measure: The change in neuronal activity during an executive functioning task response to real tDCS vs sham stimulation.
timeFrame: 1 day
Secondary outcomes:
measure: The secondary outcome measure is going to be the generalization of learning to non-trained task.
timeFrame: 3 years
Other outcomes:
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