Electrical Stimulation in Denervated Muscles of the Upper Limbs

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Collaborators:

Information provided by (Responsible Party):

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Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

September 1, 2018

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pennation angle (degrees)[ Time Frame: Baseline and after 12 weeks of electrical stimulation ]

Difference between the pennation angle of the stimulated muscle at baseline and after the stimulation period

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Muscle thickness (mm)[ Time Frame: Baseline ]
Muscle thickness at baseline
Questionaire[ Time Frame: 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

Descriptive Information

Brief Title ^ICMJE

Electrical Stimulation in Denervated Muscles of the Upper Limbs

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: Repeated measurement interventional Single Subject Design
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: Stimulation of denervated muscle
direct muscle stimulation 5 times a week for 33 minutes 3 minutes warm up 30 minutes treatment

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 30, 2019

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Swiss Paraplegic Centre Nottwil

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Jan Fridén, Prof.Dr.med. Swiss Paraplegic Centre Nottwil

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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