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

NCT ID: NCT01174641

Last Updated: 2010-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

trans-cranial magnetic stimulation

Intervention Type: OTHER

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 TMS

1 Hz trans-cranial magnetic stimulation will be applied over the vertex

Group Type: PLACEBO_COMPARATOR

trans-cranial magnetic stimulation

Intervention Type: OTHER

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

Interventions

trans-cranial magnetic stimulation

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Stroke Association, United Kingdom

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

University of Birmingham

Principal Investigators

Glyn Humphreys, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

Queen Elizabeth Hospital

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Central Contacts

Glyn W Humphreys, PhD

Role: CONTACT

g.w.humphreys@bham.ac.uk

00441214144930

Adrian Williams, MD

Role: CONTACT

adrian.williams@uhb.nhs.uk

0044121472 1311 ext. 2106

Facility Contacts

Glyn Humphreys, PhD

Role: primary

g.w.humphreys@bham.ac.uk

001214144930

Adrian Williams, MD

Role: backup

adrian.williams@uhb.nhs.uk

0444121 472 1311 ext. 2106

Other Identifiers

TSA 2010/3

Identifier Type: -

Identifier Source: org_study_id