Test of Trans-cranial Magnetic Stimulation (TMS) Intervention on Unilateral Neglect
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke |
Other: trans-cranial magnetic stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised Double-blind Test of TMS Intervention on Unilateral Neglect |
- Standardised measure of visual neglect [ Time Frame: 9 months ] [ Designated as safety issue: No ]A measure of unilateral neglect will be used
- measure of working memory [ Time Frame: 9 months ] [ Designated as safety issue: No ]a standardised measure of working memory from the Birmingham University Cognitive Screen (www.bucs.bham.ac.uk)
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TMS intervention
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
trans-cranial magnetic stimulation will be applied at 1Hz for 20 min over the ipsilesional posterior parietal cortex of stroke patients with unilateral neglect
|
|
Placebo Comparator: Placebo TMS
1 Hz trans-cranial magnetic stimulation will be applied over the vertex
|
Other: trans-cranial magnetic stimulation
1 Hz trans-cranial magnetic stimulation will be applied for 20min at 60% motor threshold over the vertex
|
Eligibility| Ages Eligible for Study: | 30 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Glyn W Humphreys, PhD | 00441214144930 | g.w.humphreys@bham.ac.uk |
| Contact: Adrian Williams, MD | 0044121472 1311 ext 2106 | adrian.williams@uhb.nhs.uk |
| United Kingdom | |
| Queen Elizabeth Hospital | Not yet recruiting |
| Birmingham, West Midlands, United Kingdom, B15 | |
| Contact: Glyn Humphreys, PhD 001214144930 g.w.humphreys@bham.ac.uk | |
| Contact: Adrian Williams, MD 0444121 472 1311 ext 2106 adrian.williams@uhb.nhs.uk | |
| Principal Investigator: | Glyn Humphreys, PhD | University of Birmingham |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Brendan Laverty, University of Birmingham |
| ClinicalTrials.gov Identifier: | NCT01174641 History of Changes |
| Other Study ID Numbers: | TSA 2010/3 |
| Study First Received: | August 2, 2010 |
| Last Updated: | August 2, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Birmingham:
|
unilateral neglect TMS intervention |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013