Brain STimulation for Arm Recovery After Stroke 2

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 parameters/endpoints: 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age, 18 years or older

• First-ever unilateral ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem;

• Unilateral upper limb paresis with a motricity index between 9 and 99;

• Possibility to start cTBS treatment within 21 days after stroke onset;

• Signed informed consent.

Locations
Other Locations
Netherlands
Tolbrug
NOT_YET_RECRUITING
's-hertogenbosch
Reade
RECRUITING
Amsterdam
Revalidatie Friesland
RECRUITING
Beetsterzwaag
Revant
RECRUITING
Breda
MRC Aardenburg
NOT_YET_RECRUITING
Doorn
Libra Blixembosch
RECRUITING
Eindhoven
University Medical Center Groningen
NOT_YET_RECRUITING
Groesbeek
Merem
RECRUITING
Hilversum
Adelante
RECRUITING
Hoensbroek
Basalt
RECRUITING
Leiden
Sint Maartenskliniek
RECRUITING
Nijmegen
Basalt
RECRUITING
The Hague
Libra Leijpark
RECRUITING
Tilburg
De Hoogstraat
RECRUITING
Utrecht
Heliomare
RECRUITING
Wijk Aan Zee
Vogellanden
RECRUITING
Zwolle
Contact Information
Primary
Jord Vink, PhD
j.j.vink-5@umcutrecht.nl
+31634959811
Time Frame
Start Date: 2024-12-09
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 454
Treatments
Experimental: Active cTBS
Active cTBS delivered with an active TMS coil
Sham_comparator: Sham cTBS
Sham cTBS delivered with a sham TMS coil
Related Therapeutic Areas
Sponsors
Leads: Jord Vink

This content was sourced from clinicaltrials.gov