NCT03947645

Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

Detailed description

Chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere. The primary outcome measure is the Fugl-Meyer Assessment for upper extremity (FM-UE), acquired at baseline, after the intervention period, and at 3 months follow-up. Secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
DEVICE	Ipsilesional stimulation	Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
DEVICE	Contralesional stimulation	Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

Timeline

• Start date: 2019-05-02
• Primary completion: 2022-02-01
• Completion: 2022-12-01
• First posted: 2019-05-13
• Last updated: 2021-09-29

Locations

1 site across 1 country: Germany