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Brain Stimulation and Cognition in Schizophrenia

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Trial information

Short Title: Brain Stimulation and Cognition in Schizophrenia

Long title: Investigating the effect of transcranial alternating current stimulation on gamma oscillations and visual perception in patients with schizophrenia: A partial-randomized, single-blind, partial-crossover study

Study website:

https://www.brainstim.co.uk/

Contact details

Study location:

The Centre for Cognitive Neuroimaging (CCNi), Hillhead Street, University of Glasgow

Principal investigator:

 Professor Peter Uhlhaas

Email: Peter.Uhlhaas@glasgow.ac.uk

 

 

Study overview

This is a single-blinded, partial crossover non-interventional study which will investigate the mechanistic role of gamma band oscillations in cognition deficits in patients with schizophrenia and identify whether trans-cranial alternating current stimulation (tACS) can modulate these oscillations as a cognitive enhancer.

This trial is led by NHS Greater Glasgow and Clyde and is financially supported by Lundbeck Pharmaceuticals. A total of 30 participants will be recruited across Scotland. NHS Greater Glasgow and Clyde have agreed to recruit up to 15 participants.

The primary objectives of this study are to – 1) measure a change in reaction and/or detection rates using Magnetoencephalography (MEG) before and after receiving tACS, and 2) change gamma band oscillations in visual regions in schizophrenia using tACS. Secondary and exploratory objectives will investigate at baseline whether neural oscillations are differentially impaired in visual versus auditory cortex as well as link these to changes in neurotransmitter systems, patients with schizophrenia and health controls will be compared to address these objectives.

Eligibility criteria

Inclusion:

  1. Written informed consent
  2. 18-55 years of age
  3. Normal to corrected vision
  4. Normal hearing levels
  5. DSM-V diagnosis of ScZ
  6. Stable AP medication for 1 month prior to visit 1, stable defined as max 25% change in dose
  7. A deficit >1 SD on RTs and/or detection rates on the visual attention task compared to controls
  8. A score on the Clinical Global Impression (CGI) Sub-Scale Severity of Illness of ≤ 4
  9. A score on the Calgary Depression Scale for Schizophrenia of score ≤ 13
  10. No Psychiatric hospitalization over the last 6 months before visit 1

Exclusion:

  1. An existing neurological disorder
  2. Metal implants in body parts
  3. Pregnancy
  4. History of epilepsy and seizures
  5. Evidence for a hearing impairment as well as a history amplyopia.
  6. Fulfilment of any of the MRI/MEG contraindications
  7. Positive drug screen at any study visit
  8. Change of medication ≤ 1 month prior to visit 1
  9. Current substance abuse, including cannabis
Study visits

Participants who meet the eligibility criteria will attend 5 study visits at CCNi. A summary of the study visits is below:

 

Visit 1 (screening) – 2 hours:

Medical history, demographic information, SCID, questionnaires and urine drug screen.

Visit 2 - 2 hours:

Psychological assessment, neuropsychology assessments, vision/hearing test and questionnaires.

Visit 3 - 2 hours:

Urine drug screen, visual attention task, questionnaires, vital signs, baseline MEG and MRI.

If a participant meets a deficit threshold on reaction times and/or detection rates on the visual attention task, the participant will be then be invited to attend visits 4 and 5.

Visit 4 - 3 hours:

Urine drug screen, visual attention task, questionnaires, vital signs, MEG and brain stimulation (tACS or sham).

Visit 5 - 3 hours:

Urine drug screen, visual attention task, questionnaires, vital signs, MEG and brain stimulation (tACS or sham).

Patient expenses

All reasonable travel expenses will be reimbursed and participants will receive £6/hour for each study visit.