Electrical Stimulation to Enhance Peripheral Nerve Regeneration

NCT02403661 | Recruiting

• 1 other identifier: Pro00000973
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to quantify the functional deficits caused by injuries to the brachial plexus and peripheral nerve in the arm. The second goal is to test the possible benefit of electrical stimulation of the injured nerve following surgery. The investigators will test whether electrical stimulation will improve hand function and nerve regeneration after repair for nerve injury. Injuries causing nerve damage in the arm and hand are common. In severe cases, functional outcomes even with surgery remain poor. Recently, electrical stimulation has been applied to injured nerves in rats. This was shown to improve nerve regeneration. These studies showed that as little as one hour of electrical stimulation was effective. Therefore, the investigators plan to test this new method of treatment to determine whether it is also helpful in humans. These will be done by using a symptom severity questionnaire, nerve conduction studies and by testing pressure sensations, hand dexterity and strength. The patients will be randomized to either the treatment or control group. Following the treatment, all baseline measurements will be reevaluated every three months for the first year and every 6 months during the second year. The timing and nature of the evaluation process will be identical in both groups.

Conditions

Peripheral Nerve Injuries

Outcome Measures

Primary Outcomes (1)

• Change in the sensory nerve action potential amplitude (uV) at 2 years .

  preop, every 3 to 6 months for 2 years

Secondary Outcomes (3)

• Change in the compound muscle action potential amplitude (mV) at 2 years

  preop, every 3 to 6 months for 2 years

• Change in the motor unit number estimation at 2 years

  preop, every 3 to 6 months for 2 years

• Change in the ability to perform hand function at 2 years.

  preop, every 3 to 6 months for 2 years

Study Arms (2)

Post surgical electrical stimulation

ACTIVE COMPARATOR

Balanced AC pulse at 20 Hz with less than 30V and 0.01 ms duration will be delivered for 1 hour.

Procedure: Post surgical electrical stimulation

Sham stimulation

PLACEBO COMPARATOR

Stimulation with the same parameters delivered only for 5 s.

Procedure: Post surgical electrical stimulation

Interventions

Post surgical electrical stimulation PROCEDURE

Post surgical electrical stimulation immediately after surgical nerve repair

Also known as: electrical stimulation

Post surgical electrical stimulation; Sham stimulation

Eligibility Criteria

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

You may qualify if:

• Patients with severe injury to the brachial plexus causing complete denervation.

You may not qualify if:

• The presence of other neurologic conditions.
• Cognitive compromise that renders the patients unable to understand and consent to the study.
• Minors younger than the age of 18.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

Related Publications (3)

• Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1.

  PMID: 19800329 RESULT

• Al-Majed AA, Tam SL, Gordon T. Electrical stimulation accelerates and enhances expression of regeneration-associated genes in regenerating rat femoral motoneurons. Cell Mol Neurobiol. 2004 Jun;24(3):379-402. doi: 10.1023/b:cemn.0000022770.66463.f7.

  PMID: 15206821 RESULT

• Brushart TM, Jari R, Verge V, Rohde C, Gordon T. Electrical stimulation restores the specificity of sensory axon regeneration. Exp Neurol. 2005 Jul;194(1):221-9. doi: 10.1016/j.expneurol.2005.02.007.

  PMID: 15899259 RESULT

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Ming Chan, MB ChB

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Chan, MB ChB

CONTACT

7804921614; ming.chan@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2013
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

CA (1)