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Electrical Stimulation in Denervated Muscles of the Upper Limbs

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03698136
Enrollment
20
Registered
2018-10-05
Start date
2018-09-01
Completion date
2020-12-31
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetraplegia

Keywords

tetraplegia, denervated muscles, electrical stimulation

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.

Interventions

OTHERStimulation 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.

Sponsors

Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Repeated measurement interventional Single Subject Design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pennation angle (degrees)Baseline and after 12 weeks of electrical stimulationDifference between the pennation angle of the stimulated muscle at baseline and after the stimulation period

Secondary

MeasureTime frameDescription
Muscle thickness (mm)BaselineMuscle thickness at baseline
Questionaire on participant perceptionafter 12 weeks of electrical stimulationParticipant perception of the treatment effectiveness scale to evaluate the feasibility of the treatment expenditure according to the benefit of the stimulation

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026