Electrical Stimulation in Denervated Muscles of the Upper Limbs

May 14, 2021 updated by: Swiss Paraplegic Centre Nottwil

Electrical Stimulation in Denervated Muscles of the Upper Limbs - Effect on Muscle Morphological Properties - A Pilot Study

In the last decade the stimulation of denervated muscles got more attention. Not at least because of the promising results of the RISE project (Use of electrical stimulation to restore standing in paraplegics with long-term denervated degenerated muscles). In this European project it was shown that electrical stimulation of denervated muscles in spinal cord injuries (SCI) increased muscle mass and improved the trophic situation of the lower extremities. Furthermore, structural altered muscle into fat- and connective tissue could be restored into contractile muscle tissue by stimulation. However, only a few studies investigated the effect of direct muscle stimulation in case of peripheral nerve damage in the upper extremities. None investigated the stimulation effect in denervated or partially denervated muscles in the upper extremities in tetraplegic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the last decade the stimulation of denervated muscles became part of the rehabilitation of spinal cord injuries (SCI). Not at least because of the promising results of the RISE project (Use of electrical stimulation to restore standing in paraplegics with long-term denervated degenerated muscles). In this European project it was shown that electrical stimulation of denervated muscles in SCI increased muscle mass and improved the trophic situation of the lower extremities. Furthermore, structural altered muscle into fat- and connective tissue could be restored into contractile muscle tissue by stimulation. However it has been shown that an extended time after SCI hinders the stimulation impact. The denervation process can be divided in four chronologically running steps. Muscle fibrillations are present some days after lesion followed by a loss of tension during electrical evoked tetanic contraction. After months a severe disorganization of the contractile structure in the muscle occurs and finally ends after years in a replacement of muscle fibers into fat tissue and collagen. The best results have been seen within three years after SCI. A stimulation protocol should be set up to start with single twitches combined with tetanic stimulation patterns according to the patients' improvements. The progression in stimulation training to elicit a tetanic contraction - 40 ms pulse duration with a pulse pause of 10 ms and bursts of 2 sec - could last some month in chronic stage after SCI. The stimulation of denervated muscles of the upper extremities gets more attention. It has been investigated that the cross sectional area of denervated muscle fibers could have been increased by early electrical stimulation. Furthermore, the changes in myosin heavy chain isoform, following denervation could be reversed. That indicates that early onset of stimulation could preserve the contractile muscle structure for possible reinnervation or further treatment options. Specially for tetraplegic patients who could benefit from nerve transfers, could win time for their decision.

Study Type

Interventional

Enrollment (Actual)

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

  • Switzerland
    • Luzern
      • Nottwil, Luzern, Switzerland, 6207
        • Swiss Paraplegic Centre Nottwil

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • traumatic or non-traumatic spinal cord injury
  • acute and subacute (≥ 6 weeks) and chronic (≥ 2 years) spinal cord injury
  • Age ≥ 18 years
  • Level of lesion C3 - Th1
  • American Spinal Injury Association Impairment Score (AIS) A/B/C/D
  • denervated M. extensor carpi ulnaris or M. abductor pollicis brevis or M. interosseus
  • Signed informed consent

Exclusion Criteria:

  • innervated or partially innervated M. extensor carpi ulnaris or M. abductor pollicis brevis or M. interosseus
  • Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc.
  • Pregnancy (anamnestic)

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
EXPERIMENTAL: Stimulation of denervated muscle
direct muscle stimulation 5 times a week for 33 minutes 3 minutes warm up 30 minutes treatment
Other: Stimulation of denervated muscles
The study investigates the effect of electrical stimulation on denervated muscles in the forearm and hand regarding muscle structure and thickness. The study will be performed on tetraplegics who have either paralysed the wrist extensor, the short thumb spreader or the muscle between the thumb and index finger.The study lasts 12 weeks and consists of an ultrasound examination at the beginning and end of the study and an intermediate stimulation phase.The stimulation takes place either during an inpatient stay or at home for 12 weeks, 5 times a week 33 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pennation angle (degrees)
Time Frame: Baseline and after 12 weeks of electrical stimulation
Difference between the pennation angle of the stimulated muscle at baseline and after the stimulation period
Baseline and after 12 weeks of electrical stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle thickness (mm)
Time Frame: Baseline
Muscle thickness at baseline
Baseline
Questionaire on participant perception
Time Frame: after 12 weeks of electrical stimulation
Participant perception of the treatment effectiveness scale to evaluate the feasibility of the treatment expenditure according to the benefit of the stimulation
after 12 weeks of electrical stimulation

Collaborators and Investigators

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

Sponsor

Swiss Paraplegic Centre Nottwil

Investigators

  • Principal Investigator: Jan Fridén, Prof.Dr.med., Swiss Paraplegic Centre Nottwil

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, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (ACTUAL)

October 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-20

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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