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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01174641
• Other study ID #: TSA 2010/3
• Status: Not yet recruiting
• Phase: N/A
• First received: August 2, 2010
• Last updated: August 2, 2010
• Start date: October 2010
• Est. completion date: September 2013

Study information

• Verified date: August 2010
• Source: University of Birmingham
• Contact: Glyn W Humphreys, PhD
• Phone: 00441214144930
• Email: g.w.humphreys[@]bham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	The Stroke Association, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardised measure of visual neglect	A measure of unilateral neglect will be used	9 months	No
Secondary	measure of working memory	a standardised measure of working memory from the Birmingham University Cognitive Screen (www.bucs.bham.ac.uk)	9 months	No

External Links

•   web page for BUCS protocol