Nerve Transfers in Post-stroke Spasticity

April 4, 2022 updated by: Olga Politikou, Medical University of Vienna

Outcome Measurements After Cognitive Nerve Transfers to Spastic Muscles in Stroke Patients

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • General Hospital of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Stroke patients with upper limb spasticity
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.
Procedure: Cognitive nerve transfers to spastic upper extremity muscles in stroke patients
Based on the fact that upper motor neuron syndrome after stroke is presented with variable clinical features, usually without affecting in the same way the entire upper extremity, we aim to investigate the efficacy of nerve transfers to spastic muscles after stroke using as donor nerves that innervate unaffected ipsilateral volitionally controlled muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-24 months
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 .
0-24 months
Changes in electrophysiological muscle activity after nerve transfers
Time Frame: 0-24 months
Low frequency-dependent depression of H-wave (in mV)
0-24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in muscle satellite cell population (%) in spastic muscles and comparison with healthy control group
Time Frame: During surgery- 24 months
Muscle biopsies from spastic muscles will be obtained during the surgery of nerve transfers. The muscle satellite cell population (%) will be calculated with the use of Flow Cytometry and be compared to the one of healthy muscles of control group. There will be no recruitment procedure for the control group. Routinely, when we carry out surgery for ulnar nerve release in the elbow and nerve transposition, a part of the flexor carpi ulnaris muscle needs to be excised and discarded. After obtaining informed consent from patients for further use of their biological material, we will collect these muscles and use them as control group.
During surgery- 24 months
The Action Research Arm Test (ARAT)
Time Frame: 0-24 months
The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.
0-24 months
The Disabilities of the Arm, Shoulder and Hand (DASH) score
Time Frame: 0-24 months
Scores range from 0 (no disability) to 100 (most severe disability).
0-24 months
Motor Unit Number Estimation of donor and spastic muscles
Time Frame: 0-24 months
High density electromyography with fine needle electrodes will be applied to allow an accurate estimation of motor units (absolute number) in donor muscles, in spastic muscles and in newly-innervated muscles
0-24 months
Comparison of collagen content between spastic and healthy muscles
Time Frame: During surgery- 12 months
Muscle biopsies from spastic muscles will be obtained during the surgery of nerve transfers. Collagen content of spastic muscles (%) will be calculated with the use of Picrosirius red staining and bright field light microscopy and be compared with healthy muscles of control group. There will be no recruitment procedure for the control group. Routinely, when we carry out surgery for ulnar nerve release in the elbow and nerve transposition, a part of the flexor carpi ulnaris muscle needs to be excised and discarded. After obtaining informed consent from patients for further use of their biological material, we will collect these muscles and use them as control group.
During surgery- 12 months
Changes in sarcomere length (μm) in spastic muscles
Time Frame: During surgery- 12 months
Biopsy of a muscle fascicle from spastic muscles will be obtained during the surgery of nerve transfers with the use of dedicated clamps and will be fixed in formalin. The sarcomere length will be calculated with the use of fractional laser. The sarcomere length of spastic muscles will be compared with the sarcomere length of healthy control group muscles.
During surgery- 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Imperial College London
Shirley Ryan AbilityLab

Investigators

  • Study Director: Oskar Aszmann, Prof, Department of Surgery, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (ACTUAL)

June 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 2319/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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