Conditioning Electrical Stimulation to Improve Outcomes in Carpal Tunnel Syndrome

NCT04191538 | Completed Phase 1

• 1 other identifier: CES of CTS
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal tunnel syndrome is common, identified in 3% of the general population. Symptoms including numbness and pain are due to compression of the median nerve as it travels through a tunnel entering the wrist and can result in weakened grip strength and poor dexterity. Despite surgical release, nerve damage due to chronic compression often cannot be completely reversed, with resulting sensorimotor deficits. Postoperative electrical stimulation (ES) has been well-reported to improve nerve regeneration and is currently standard of practice at our institution. Investigators of this study have recently shown in an animal model that by changing the timing of the ES from postoperative to preoperative, this "conditioning" electrical stimulation (CES) significantly improves nerve regeneration. Patients with severe carpal tunnel syndrome will be identified in plastic surgery clinics. Patients who consent to participating will undergo baseline testing including nerve conduction studies, sensory evaluation, motor testing, and patient-reported outcomes. Participants will be randomized to three groups: i) CES, ii) postoperative ES, and iii) no ES. CES will be delivered in clinic by placing a percutaneous needle alongside the median nerve, and stimulation will be delivered for one hour, with patient comfort dictating the voltage of stimulation. At the completion of one hour, the needle will be removed, and a standard carpal tunnel release will be performed by their plastic surgeon 4-7 days later. Patients will the second cohort will undergo postoperative ES immediately following their carpal tunnel release, using the same stimulation parameters as CES. The third cohort will receive only carpal tunnel release without stimulation.In all patients, sensory and motor reinnervation, using the same testing modalities as preoperative assessment, will be evaluated at 3, 6, and 12 months post-operative.

Conditions

Carpal Tunnel Syndrome

Keywords

Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• Sensory reinnervation

  Patients will be tested for 2-point discrimination and touch (Semmes-Weinstein filaments)

  Compare with baseline function to that at 12 months

• Motor reinnervation

  Purdue Pegboard Test

  Compare with baseline function to that at 12 months

• Patient-reported outcome

  Disabilities of the Arm, Shoulder and Hand questionnaire

  Compare with baseline function to that at 12 months

Study Arms (3)

Conditioning electrical stimulation

EXPERIMENTAL

Patients will receive percutaneous electrical stimulation one week prior to carpal tunnel release. They will receive sham stimulation immediately after surgery to ensure blinding.

Procedure: Conditioning electrical stimulation

Postoperative electrical stimulation

ACTIVE COMPARATOR

Patients will receive electrical stimulation immediately following carpal tunnel release, per out previous studies. They will receive sham stimulation 1 week prior to surgery to ensure blinding.

Procedure: Postoperative electrical stimulation

No electrical stimulation

SHAM COMPARATOR

Patients will not receive electrical stimulation. They will receive electrical stimulation before and after surgery to ensure blinding.

Procedure: No electrical stimulation

Interventions

Conditioning electrical stimulation PROCEDURE

Percutaneously, a small needle will be placed alongside the median nerve. Patients will receive 1 hour of 20Hz stimulation with voltage titrated to maintain patient comfort.

Conditioning electrical stimulation

Postoperative electrical stimulation PROCEDURE

Immediately following carpal tunnel release, needles for electrical stimulation will be placed alongside the visualized median nerve. Patients will receive 1 hour of 20Hz stimulation with voltage titrated to maintain patient comfort.

Postoperative electrical stimulation

No electrical stimulation PROCEDURE

Patients will receive sham stimulation (needles placed, no current delivered) pre- and post-operatively; however, no current will ever be delivered to the nerve. This is the control cohort.

No electrical stimulation

Eligibility Criteria

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

You may qualify if:

• Severe carpal tunnel syndrome (per screening nerve conduction test - thenar motor unit loss minimum two standard deviations between the mean for the age group)
• Failed conservative treatment (requires surgical intervention)

You may not qualify if:

• Preexisting neuropathy

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (2)

• 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 BACKGROUND

• Senger JLB, Verge VMK, Macandili HSJ, Olson JL, Chan KM, Webber CA. Electrical stimulation as a conditioning strategy for promoting and accelerating peripheral nerve regeneration. Exp Neurol. 2018 Apr;302:75-84. doi: 10.1016/j.expneurol.2017.12.013. Epub 2017 Dec 29.

  PMID: 29291403 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized by an objective third party, who will provide electrical stimulation at the appropriate time given randomized cohort. Patients, surgeon, and investigator will be unaware of arm of study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: January 1, 2020
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)