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

University of Birmingham

Status

Unknown

Conditions

Stroke

Treatments

Other: trans-cranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01174641

TSA 2010/3

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

30 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

TMS intervention

Experimental group

Description:

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

Treatment:

Other: trans-cranial magnetic stimulation

Placebo TMS

Placebo Comparator group

Description:

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

Treatment:

Other: trans-cranial magnetic stimulation