Test of Trans-cranial Magnetic Stimulation (TMS) Intervention on Unilateral Neglect
A Randomised Double-blind Test of TMS Intervention on Unilateral Neglect
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Oct 2010
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 3, 2010
August 1, 2010
2.9 years
August 2, 2010
August 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standardised measure of visual neglect
A measure of unilateral neglect will be used
9 months
Secondary Outcomes (1)
measure of working memory
9 months
Study Arms (2)
TMS intervention
EXPERIMENTALTrans-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
PLACEBO COMPARATOR1 Hz trans-cranial magnetic stimulation will be applied over the vertex
Interventions
1 Hz trans-cranial magnetic stimulation will be applied for 20min at 60% motor threshold over the vertex
Eligibility Criteria
You may qualify if:
- presence of left unilateral neglect after right hemisphere stroke
You may not qualify if:
- presence of epilepsy/family history of epilepsy
- insufficient comprehension to follow instructions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- The Stroke Association, United Kingdomcollaborator
Study Sites (1)
Queen Elizabeth Hospital
Birmingham, West Midlands, B15, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glyn Humphreys, PhD
University of Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 3, 2010
Study Start
October 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 3, 2010
Record last verified: 2010-08