Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381388
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-17
Brief Title:
Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke
Sponsor:
Jord Vink
Organization:
UMC Utrecht
Study Overview
Official Title:
Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InterAct
Brief Summary:
Rationale Acute stroke leaves many patients with functional deficits of which upper extremity motor impairment is one of the most disabling Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain Non-invasive brain stimulation methods like transcranial magnetic stimulation TMS can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke Application of continuous theta burst stimulation cTBS an inhibitory form of TMS to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke However responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear
Objective To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments Age-matched healthy persons will serve as controls
Study design A prospective open-label within-subject intervention study
Study population 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity and 40 age-matched controls
Main endpoints Primary endpoint Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex Secondary endpoints contralesional intracortical inhibition effect of contralesional TMS interference on finger tapping frequency
Objective To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments Age-matched healthy persons will serve as controls
Study design A prospective open-label within-subject intervention study
Study population 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity and 40 age-matched controls
Main endpoints Primary endpoint Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex Secondary endpoints contralesional intracortical inhibition effect of contralesional TMS interference on finger tapping frequency
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None