Nerve Transfers in Post-stroke Spasticity

Medical University of Vienna

Status: Invitation-only

Conditions: Nerve Transfers; Spasticity as Sequela of Stroke

Treatments: Procedure: Cognitive nerve transfers to spastic upper extremity muscles in stroke patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04437056

EK 2319/2019

Details and patient eligibility

About

Stroke is nowadays a leading cause of disability with devastating sequelae. Upper limb spasticity is one of them. Nevertheless, not all the muscles are equally affected, as some may turn spastic or paretic and other remain intact. This unique pathophysiological mosaic dictates a precise therapeutic plan. Existing spasticity treatment has significant drawbacks due to its unspecific targeting and short duration. A causal, life-lasting treatment, precisely adapted to every single patient's needs and to disease pattern, is currently missing. Hyperselective muscle denervation and subsequent cognitive reinnervation with appropriate unaffected donor nerves may break the pathological spastic circuit and provide volitional muscle control. With this pioneering study we will perform cognitive nerve transfers to spastic muscles and will prospectively investigate their effects on clinical, electrophysiological, molecular-biological and histological level. Accurate donor nerve selection will be for the first time quantified through motor unit number estimation with high-density needle electromyography. This revolutionary concept can open the window to a new era of therapeutic possibilities for stroke victims.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are undergoing nerve transfers
• Age from 18 to 75 years old
• Minimum of 1 year interval after stroke
• Are able to understand German or English
• Medical Research Council (MRC) Muscle scale for donor nerves: M4 or M5
• Walking patients, with or without crutches
• Good general health condition and social support

For the control group:

• Age 18-75 years old
• Indication for ulnar nerve release and submuscular transposition for compression neuropathy in the elbow
• No other neurological disorders

Exclusion criteria

• Stroke earlier than 3 years at the time of first consultation
• Lower limb spasticity and patients mobile with wheel chair

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Stroke patients with upper limb spasticity

Other group

Description:

Patients with post-stroke upper limb spasticity will be operated for cognitive nerve transfers to spastic muscles to allow for volitional muscle reinnervation and disrupture of spasticity. Adequate healthy nerve donors from the ipsilateral arm will be determined clinically and electrophysiologically.

Treatment:

Procedure: Cognitive nerve transfers to spastic upper extremity muscles in stroke patients