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Electrical Stimulation in Denervated Muscles of the Upper Limbs

Primary Purpose

Tetraplegia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Stimulation of denervated muscles
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tetraplegia focused on measuring tetraplegia, denervated muscles, electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Swiss Paraplegic Centre Nottwil

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stimulation of denervated muscle

Arm Description

direct muscle stimulation 5 times a week for 33 minutes 3 minutes warm up 30 minutes treatment

Outcomes

Primary Outcome Measures

Pennation angle (degrees)
Difference between the pennation angle of the stimulated muscle at baseline and after the stimulation period

Secondary Outcome Measures

Muscle thickness (mm)
Muscle thickness at baseline
Questionaire on participant perception
Participant perception of the treatment effectiveness scale to evaluate the feasibility of the treatment expenditure according to the benefit of the stimulation

Full Information

First Posted
October 1, 2018
Last Updated
May 14, 2021
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT03698136
Brief Title
Electrical Stimulation in Denervated Muscles of the Upper Limbs
Official Title
Electrical Stimulation in Denervated Muscles of the Upper Limbs - Effect on Muscle Morphological Properties - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia
Keywords
tetraplegia, denervated muscles, electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measurement interventional Single Subject Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation of denervated muscle
Arm Type
Experimental
Arm Description
direct muscle stimulation 5 times a week for 33 minutes 3 minutes warm up 30 minutes treatment
Intervention Type
Other
Intervention Name(s)
Stimulation of denervated muscles
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pennation angle (degrees)
Description
Difference between the pennation angle of the stimulated muscle at baseline and after the stimulation period
Time Frame
Baseline and after 12 weeks of electrical stimulation
Secondary Outcome Measure Information:
Title
Muscle thickness (mm)
Description
Muscle thickness at baseline
Time Frame
Baseline
Title
Questionaire on participant perception
Description
Participant perception of the treatment effectiveness scale to evaluate the feasibility of the treatment expenditure according to the benefit of the stimulation
Time Frame
after 12 weeks of electrical stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Fridén, Prof.Dr.med.
Organizational Affiliation
Swiss Paraplegic Research, Nottwil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Centre Nottwil
City
Nottwil
State/Province
Luzern
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29358674
Citation
Bersch I, Koch-Borner S, Friden J. Electrical stimulation-a mapping system for hand dysfunction in tetraplegia. Spinal Cord. 2018 May;56(5):516-522. doi: 10.1038/s41393-017-0042-2. Epub 2018 Jan 22.
Results Reference
background
PubMed Identifier
15725217
Citation
Modlin M, Forstner C, Hofer C, Mayr W, Richter W, Carraro U, Protasi F, Kern H. Electrical stimulation of denervated muscles: first results of a clinical study. Artif Organs. 2005 Mar;29(3):203-6. doi: 10.1111/j.1525-1594.2005.29035.x.
Results Reference
background
PubMed Identifier
15926978
Citation
Helgason T, Gargiulo P, Johannesdottir F, Ingvarsson P, Knutsdottir S, Gudmundsdottir V, Yngvason S. Monitoring muscle growth and tissue changes induced by electrical stimulation of denervated degenerated muscles with CT and stereolithographic 3D modeling. Artif Organs. 2005 Jun;29(6):440-3. doi: 10.1111/j.1525-1594.2005.29073.x.
Results Reference
background
PubMed Identifier
26121368
Citation
Gordon T, English AW. Strategies to promote peripheral nerve regeneration: electrical stimulation and/or exercise. Eur J Neurosci. 2016 Feb;43(3):336-50. doi: 10.1111/ejn.13005. Epub 2015 Aug 14.
Results Reference
background
PubMed Identifier
15453091
Citation
Kern H, Boncompagni S, Rossini K, Mayr W, Fano G, Zanin ME, Podhorska-Okolow M, Protasi F, Carraro U. Long-term denervation in humans causes degeneration of both contractile and excitation-contraction coupling apparatus, which is reversible by functional electrical stimulation (FES): a role for myofiber regeneration? J Neuropathol Exp Neurol. 2004 Sep;63(9):919-31. doi: 10.1093/jnen/63.9.919.
Results Reference
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Electrical Stimulation in Denervated Muscles of the Upper Limbs

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