Electrical Stimulation in Denervated Muscles of the Upper Limbs

NCT03698136 | Completed DMC

• 1 other identifier: 2018-20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetraplegia

Keywords

tetraplegia; denervated muscles; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Pennation angle (degrees)

  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 Outcomes (2)

• Muscle thickness (mm)

  Baseline

• Questionaire on participant perception

  after 12 weeks of electrical stimulation

Study Arms (1)

Stimulation of denervated muscle

EXPERIMENTAL

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

Other: Stimulation of denervated muscles

Interventions

Stimulation of denervated muscles 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.

Stimulation of denervated muscle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 29358674 BACKGROUND

• 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.

  PMID: 15725217 BACKGROUND

• 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.

  PMID: 15926978 BACKGROUND

• 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.

  PMID: 26121368 BACKGROUND

• 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.

  PMID: 15453091 BACKGROUND

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Fridén, Prof.Dr.med.

  Swiss Paraplegic Research, Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Repeated measurement interventional Single Subject Design

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 5, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 3, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)