Electrical Stimulation in Denervated Muscles of the Upper Limbs

Not Applicable

Completed

• Conditions: Tetraplegia
• Interventions: Other: Stimulation of denervated muscles

• Registration Number: NCT03698136
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation of denervated muscle	Stimulation of denervated muscles	direct muscle stimulation 5 times a week for 33 minutes 3 minutes warm up 30 minutes treatment

Primary Outcome Measures

Name	Time	Method
Pennation angle (degrees)	Baseline and after 12 weeks of electrical stimulation	Difference between the pennation angle of the stimulated muscle at baseline and after the stimulation period

Secondary Outcome Measures

Name	Time	Method
Questionaire on participant perception	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
Muscle thickness (mm)	Baseline	Muscle thickness at baseline

Trial Locations

Locations (1)

Swiss Paraplegic Centre Nottwil; 🇨🇭 Nottwil, Luzern, Switzerland