Electrical Stimulation in Denervated Muscles of the Upper Limbs

Tetraplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698136
• Other study ID #: 2018-20
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Quadriplegia
• Tetraplegia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre Nottwil	Nottwil	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Bersch I, Koch-Borner S, Fridén 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. — View 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. Review. — View Citation

Helgason T, Gargiulo P, Jóhannesdóttir F, Ingvarsson P, Knútsdóttir S, Gudmundsdóttir 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. — View Citation

Kern H, Boncompagni S, Rossini K, Mayr W, Fanò 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. — View Citation

Mödlin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle thickness (mm)	Muscle thickness at baseline	Baseline
Secondary	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	after 12 weeks of electrical stimulation