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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Birmingham.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
The Stroke Association, United Kingdom
Information provided by:
University of Birmingham
ClinicalTrials.gov Identifier:
NCT01174641
First received: August 2, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • Standardised measure of visual neglect [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    A measure of unilateral neglect will be used


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174641

Contacts
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

Locations
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   
Sponsors and Collaborators
University of Birmingham
The Stroke Association, United Kingdom
Investigators
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 August 28, 2014