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Electrical Stimulation in Denervated Muscles of the Upper Limbs

NCT ID: NCT03698136

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Tetraplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Repeated measurement interventional Single Subject Design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stimulation of denervated muscle

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

Group Type EXPERIMENTAL

Stimulation of denervated muscles

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Fridén, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Research, Nottwil

Locations

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Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 29358674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15725217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15926978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26121368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15453091 (View on PubMed)

Other Identifiers

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2018-20

Identifier Type: -

Identifier Source: org_study_id