Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-31
Brief Title:
Brain STimulation for Arm Recovery After Stroke 2
Sponsor:
Jord Vink
Organization:
UMC Utrecht
Study Overview
Official Title:
Brain STimulation for Arm Recovery After Stroke 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
B-STARS2
Brief Summary:
Rationale Every year about 40000 people in the Netherlands have a stroke After the initial admission to the hospital about 15 of stroke survivors is admitted to a rehabilitation center because of remaining disabilities Three out of four of these patients have upper limb dysfunction hampering activities of daily living Upper limb function plays a critical role in the performance of most daily life activities In our phase II trial B-STARS continuous theta burst stimulation cTBS treatment led to an absolute additional recovery of upper limb function of 17 as measured with the Action Research Arm Test ARAT score three months after stroke This improvement exceeds the minimal clinically important difference of 10 cTBS treatment also resulted in a significant improvement in measures of activities and participation of similar magnitude and a reduction in the mean length of stay at the rehabilitation center by 18 days
Objective To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center
Study design A phase III multi-center double-blind randomized sham-controlled clinical trial
Study population 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis defined by a Motricity Index between 9 and 99 in whom cTBS treatment can be started within 3 weeks after stroke onset
Intervention 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks delivered immediately before regular care physical therapy of the affected upper limb
Main study parametersendpoints The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment FM-UE at 90 days after stroke Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test Nine Hole Peg Test Stroke Impact Scale EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke
Objective To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center
Study design A phase III multi-center double-blind randomized sham-controlled clinical trial
Study population 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis defined by a Motricity Index between 9 and 99 in whom cTBS treatment can be started within 3 weeks after stroke onset
Intervention 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks delivered immediately before regular care physical therapy of the affected upper limb
Main study parametersendpoints The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment FM-UE at 90 days after stroke Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test Nine Hole Peg Test Stroke Impact Scale EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 85511 | OTHER | ABR number | None |