Improving Cognition in Schizophrenia Using Non-invasive Brain Stimulation

NCT ID: NCT04184830

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-03-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tDCS arm

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).

Group Type: EXPERIMENTAL

non-invasive brain stimulation

Intervention Type: DEVICE

tDCS sham

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).

Group Type: SHAM_COMPARATOR

non-invasive brain stimulation

Intervention Type: DEVICE

Interventions

non-invasive brain stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Orlov ND, Muqtadir SA, Oroojeni H, Averbeck B, Rothwell J, Shergill SS. Stimulating learning: A functional MRI and behavioral investigation of the effects of transcranial direct current stimulation on stochastic learning in schizophrenia. Psychiatry Res. 2022 Nov;317:114908. doi: 10.1016/j.psychres.2022.114908. Epub 2022 Oct 14.

Reference Type: DERIVED

PMID: 37732853 (View on PubMed)

Other Identifiers

11/LO/0248

Identifier Type: -

Identifier Source: org_study_id