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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174641
Recruitment Status : Unknown
Verified August 2010 by University of Birmingham.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2010
Last Update Posted : August 3, 2010
The Stroke Association, United Kingdom
Information provided by:
University of Birmingham

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.

Condition or disease Intervention/treatment Phase
Stroke Other: trans-cranial magnetic stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Double-blind Test of TMS Intervention on Unilateral Neglect
Study Start Date : October 2010
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Standardised measure of visual neglect [ Time Frame: 9 months ]
    A measure of unilateral neglect will be used

Secondary Outcome Measures :
  1. measure of working memory [ Time Frame: 9 months ]
    a standardised measure of working memory from the Birmingham University Cognitive Screen (

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01174641

Contact: Glyn W Humphreys, PhD 00441214144930
Contact: Adrian Williams, MD 0044121472 1311 ext 2106

United Kingdom
Queen Elizabeth Hospital Not yet recruiting
Birmingham, West Midlands, United Kingdom, B15
Contact: Glyn Humphreys, PhD    001214144930   
Contact: Adrian Williams, MD    0444121 472 1311 ext 2106   
Sponsors and Collaborators
University of Birmingham
The Stroke Association, United Kingdom
Principal Investigator: Glyn Humphreys, PhD University of Birmingham

Additional Information:
Responsible Party: Dr Brendan Laverty, University of Birmingham Identifier: NCT01174641     History of Changes
Other Study ID Numbers: TSA 2010/3
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: August 2010

Keywords provided by University of Birmingham:
unilateral neglect
TMS intervention