Test of Trans-cranial Magnetic Stimulation (TMS) Intervention on Unilateral Neglect

Study Overview
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Brief Summary
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Problems in attention can affect around 40% of stroke survivors and are associated with poor recovery of function. This project will provide the largest scale and most detailed examination to date of whether problems in attention after stroke can be remediated through direct brain stimulation. In Part 1 of the project the investigators will use two forms of direct brain stimulation (neural inhibition) to try and balance activity across the two sides of the brain following a stroke to one side. The investigators will assess whether each form of stimulation leads to an improvement in attentional functions, as well as to wider improvements in other cognitive abilities and to activities of everyday living. Performance will be tested immediately post remediation and on longer-term follow-up, and performance of the two intervention groups will be assessed against data the investigators have collected from a large-scale screen of cognitive impairments and recovery of function under standard treatment conditions. In Part 2 of the project the investigators will take the most promising intervention from Part 1 and the investigators will use magnetic resonance imaging (MRI) to determine the brain changes that are linked to the recovery of attentional functions. The investigators will test whether recovery is linked to a change in the balance of activation within the two hemispheres of the brain, and whether there are associated structural changes in cortical tissue and fibre tracts. The project will evaluate whether neural inhibition can improve attentional functions in particular, and cognitive abilities and everyday activities more generally, in stroke survivors. It will also provide novel information on how recovery of function comes about within the brain.

Official Title
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A Randomised Double-blind Test of TMS Intervention on Unilateral Neglect

Conditions
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Stroke

Intervention / Treatment
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* Other: trans-cranial magnetic stimulation
* Other: trans-cranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of left unilateral neglect after right hemisphere stroke Exclusion Criteria: presence of epilepsy/family history of epilepsy insufficient comprehension to follow instructions

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS intervention<br>Trans-cranial magnetic stimulation will be applied at a 1Hz rate for 20min over the ipsilesional posterior parietal cortex of patients showing left neglect after a right hemisphere stroke | Other: trans-cranial magnetic stimulation<br>* trans-cranial magnetic stimulation will be applied at 1Hz for 20 min over the ipsilesional posterior parietal cortex of stroke patients with unilateral neglect<br>|
| Placebo Comparator: Placebo TMS<br>1 Hz trans-cranial magnetic stimulation will be applied over the vertex | Other: trans-cranial magnetic stimulation<br>* 1 Hz trans-cranial magnetic stimulation will be applied for 20min at 60% motor threshold over the vertex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardised measure of visual neglect | A measure of unilateral neglect will be used | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of working memory | a standardised measure of working memory from the Birmingham University Cognitive Screen (www.bucs.bham.ac.uk) | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unilateral neglect, TMS intervention