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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01174641
Enrollment
100
Registered
2010-08-03
Start date
2010-10-31
Completion date
2013-09-30
Last updated
2010-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

unilateral neglect, TMS intervention

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.

Interventions

1 Hz trans-cranial magnetic stimulation will be applied for 20min at 60% motor threshold over the vertex

Sponsors

The Stroke Association, United Kingdom
CollaboratorOTHER
University of Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Standardised measure of visual neglect9 monthsA measure of unilateral neglect will be used

Secondary

MeasureTime frameDescription
measure of working memory9 monthsa standardised measure of working memory from the Birmingham University Cognitive Screen (www.bucs.bham.ac.uk)

Countries

United Kingdom

Contacts

Primary ContactGlyn W Humphreys, PhD
g.w.humphreys@bham.ac.uk00441214144930
Backup ContactAdrian Williams, MD
adrian.williams@uhb.nhs.uk0044121472 1311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026