Improving Cognition in Schizophrenia Using Non-invasive Brain Stimulation

King's College London

Status: Completed

Conditions: Schizophrenia

Treatments: Device: non-invasive brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04184830

11/LO/0248

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

tDCS arm

Experimental group

Description:

Active stimulation: Direct current will be transferred using a pair of saline-soaked surface sponge electrodes (5x7). For anodal stimulation of the left DLPFC the anode will be placed over the site of F3, according to the 10-20 international system for electroencephalogram electrode placement. The cathode will be placed over the right supraorbital area. A constant current of 2mA will be applied for 30 minutes, which will result in current density of 0.08 mA/cm².In order to avoid side effects, as a result of electrical transient (e.g. tingling and burning sensation), the current will be ramped for 10 seconds at the beginning and end of stimulation (Nitsche et al., 2008).

Treatment:

Device: non-invasive brain stimulation

tDCS sham

Sham Comparator group

Description:

Sham stimulation: During the sham stimulation a pair of saline-soaked surface sponge electrodes (5x7) will be places on the scalp For sham stimulation of the left DLPFC the anode will be placed over the site of F3, according to the 10-20 international system for electroencephalogram electrode placement. The cathode will be placed over the right supraorbital area. A constant current of 2mA will be applied for 30 seconds.In order to avoid side effects, as a result of electrical transient (e.g. tingling and burning sensation), the current will be ramped for 10 seconds at the beginning and end of stimulation (Nitsche et al., 2008).

Treatment:

Device: non-invasive brain stimulation