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

Not Applicable

• Conditions: Stroke
• Interventions: Other: trans-cranial magnetic stimulation

• Registration Number: NCT01174641
• Lead Sponsor: University of Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Last Update Submitted: 2010-08-02
• Study First Posted: 2010-08-03
• Last Update Posted: 2010-08-03
• Study Start: 2010-10
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS intervention	trans-cranial magnetic stimulation	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
Placebo TMS	trans-cranial magnetic stimulation	1 Hz trans-cranial magnetic stimulation will be applied over the vertex

Primary Outcome Measures

Name	Time	Method
Standardised measure of visual neglect	9 months	A measure of unilateral neglect will be used

Secondary Outcome Measures

Name	Time	Method
measure of working memory	9 months	a standardised measure of working memory from the Birmingham University Cognitive Screen (www.bucs.bham.ac.uk)

Trial Locations

Locations (1)

Queen Elizabeth Hospital; 🇬🇧 Birmingham, West Midlands, United Kingdom