Outcome Measurements After Cognitive Nerve Transfers to Spastic Muscles in Stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spasticity as Sequela of Stroke
- Sponsor
- Medical University of Vienna
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Chedoke Arm and Hand Activity Inventory (CAHAI-9) score
- Status
- Enrolling By Invitation
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Olga Politikou
MD, Principal Investigator, PhD Student Clinical Laboratory for Bionic Extremity Reconstruction
Medical University of Vienna
Eligibility Criteria
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
Exclusion Criteria
- •Stroke earlier than 3 years at the time of first consultation
- •Lower limb spasticity and patients mobile with wheel chair
Outcomes
Primary Outcomes
Chedoke Arm and Hand Activity Inventory (CAHAI-9) score
Time Frame: 0-24 months
Patients can reach a score for CAHAI 9 between 9 to 63. The lower the score, the greater impairment.
Changes in electrophysiological muscle activity after nerve transfers
Time Frame: 0-24 months
Low frequency-dependent depression of H-wave (in mV)
Modified Ashworth Scale
Time Frame: 0-24 months
A score of 1 indicates no resistance, and 5 indicates rigidity. A 1+ scoring category indicates resistance through less than half of the movement. Scores range from 0-4, with 6 choices .
Secondary Outcomes
- The Action Research Arm Test (ARAT)(0-24 months)
- The Disabilities of the Arm, Shoulder and Hand (DASH) score(0-24 months)
- Changes in muscle satellite cell population (%) in spastic muscles and comparison with healthy control group(During surgery- 24 months)
- Changes in sarcomere length (μm) in spastic muscles(During surgery- 12 months)
- Motor Unit Number Estimation of donor and spastic muscles(0-24 months)
- Comparison of collagen content between spastic and healthy muscles(During surgery- 12 months)