Nerve Root Block in Spasticity

NCT06868342 | Completed

• 1 other identifier: RG420-21
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

In this work the investigators propose to briefly apply kilohertz frequency alternating current via PNS device placed next to the isolated nerve in 4 patients undergoing peripheral neurectomy, just before cutting the nerve. The intervention shall be performed utilizing EMG monitoring and mapping. After the muscular branches of the tibial nerve are exposed, proximal stimulation (1Hz) shall be applied to a selected branch with a bipolar electrode to produce muscle contractions. A high frequency (10kHz) blocking current shall be applied by placing a PNS electrode distally to the bipolar electrode and the EMG shall be recorded. The PNS electrode shall be removed from surgical field and further proximal stimulation done to confirm reversal of block (return to baseline) on the EMG. Then the nerve will be severed as a part of standard tibial neurectomy, and further proximal and distal stimulation shall be performed. The results will be compared to see if high frequency conduction block can physiologically mimic peripheral neurectomy; and obtain parameters of stimulation required for that.

Conditions

Spasticity; Spasticity in Participants With Multiple Sclerosis; Spasticity Post Stroke; Spasticity Related to Any Cause Except Cerebral Palsy

Keywords

Spasticity; High-Frequency Stimulation; Electrical Nerve Block; Conduction Block

Outcome Measures

Primary Outcomes (3)

• EMG - Nerve conduction block

  Following the application of the high-frequency current to the distal part of the nerve, the stimulated EMG shall show the decrease in amplitude \[uV\], compared to baseline EMG.

  Intraoperative.

• EMG - The reversibility of nerve conduction block

  After stopping the high-frequency stimulation, the stimulated EMG amplitudes shall return to baseline \[uV\].

  Intraoperative.

• EMG - Comparative analysis of the effects of nerve block vs. neurectomy.

  After the nerve block is reversed, a standard tibial neurectomy shall be performed. Stimulated EMG amplitudes \[uV\] shall be compared to those recorded at the time of nerve block \[uV\].

  Intraoperative

Study Arms (1)

Nerve block

EXPERIMENTAL

The group of participants undergoing tibial neurectomy for focal spasticity to whom the high frequency nerve conduction block shall be applied.

Procedure: High-frequency nerve conduction block

Interventions

High-frequency nerve conduction block PROCEDURE

A high-frequency nerve conduction block applied to a muscular branch of the tibial nerve and assessed by intraoperative EMG, performed before the nerve is cut as a part of a standard tibial neurectomy for focal spasticity.

Also known as: HFNB

Nerve block

Eligibility Criteria

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

You may qualify if:

• Male or Female, aged 18 years or above selected for peripheral neurectomy for focal spasticity
• Functioning LMN pathway determined by EMG

You may not qualify if:

• Age \<18yr
• Myopathy and other LMN disorders
• Impaired LMN pathway determined by EMG

Sponsors & Collaborators

• Walton Centre NHS Foundation Trust: lead
• Nevro Corp: collaborator

Study Sites (1)

The Walton Centre NHS Foundation Trust

Liverpool, L9 7LJ, United Kingdom

Location

Related Publications (10)

• Sitthinamsuwan B, Chanvanitkulchai K, Phonwijit L, Ploypetch T, Kumthornthip W, Nunta-Aree S. Utilization of intraoperative electromyography for selecting targeted fascicles and determining the degree of fascicular resection in selective tibial neurotomy for ankle spasticity. Acta Neurochir (Wien). 2013 Jun;155(6):1143-9. doi: 10.1007/s00701-013-1686-0. Epub 2013 Apr 7.

  PMID: 23563747 BACKGROUND

• Deer TR, Naidu R, Strand N, Sparks D, Abd-Elsayed A, Kalia H, Hah JM, Mehta P, Sayed D, Gulati A. A review of the bioelectronic implications of stimulation of the peripheral nervous system for chronic pain conditions. Bioelectron Med. 2020 Apr 24;6:9. doi: 10.1186/s42234-020-00045-5. eCollection 2020.

  PMID: 32346553 BACKGROUND

• Mikalef P, Power D. The role of neurectomy in the management of spasticity of the upper limb. EFORT Open Rev. 2017 Nov 27;2(11):469-473. doi: 10.1302/2058-5241.2.160074. eCollection 2017 Nov.

  PMID: 29218232 BACKGROUND

• Yong LY, Wong CHL, Gaston M, Lam WL. The Role of Selective Peripheral Neurectomy in the Treatment of Upper Limb Spasticity. J Hand Surg Asian Pac Vol. 2018 Jun;23(2):181-191. doi: 10.1142/S2424835518500182.

  PMID: 29734901 BACKGROUND

• Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation. 2013 Jan-Feb;16(1):59-65; discussion 65-6. doi: 10.1111/ner.12006. Epub 2012 Nov 30.

  PMID: 23199157 BACKGROUND

• Camilleri M, Toouli J, Herrera MF, Kow L, Pantoja JP, Billington CJ, Tweden KS, Wilson RR, Moody FG. Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device. Surg Obes Relat Dis. 2009 Mar-Apr;5(2):224-9; discussion 229-30. doi: 10.1016/j.soard.2008.09.006. Epub 2008 Sep 12.

  PMID: 18996767 BACKGROUND

• Soin A. Long-term human testing of high-frequency nerve block for amputation pain. Paper presented at: 16th Annual Meeting North American Neuromodulation Society; December 6 to 9, 2012; Las Vegas, NV, USA.

  BACKGROUND

• Perruchoud C, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20.

  PMID: 23425338 BACKGROUND

• Bhadra N, Vrabec TL, Bhadra N, Kilgore KL. Reversible conduction block in peripheral nerve using electrical waveforms. Bioelectron Med (Lond). 2018 Jan;1(1):39-54. doi: 10.2217/bem-2017-0004. Epub 2017 Dec 14.

  PMID: 29480897 BACKGROUND

• Kilgore KL, Bhadra N. Nerve conduction block utilising high-frequency alternating current. Med Biol Eng Comput. 2004 May;42(3):394-406. doi: 10.1007/BF02344716.

  PMID: 15191086 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Heart Block

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes

Study Officials

• Andrew Marshall, PhD

  Walton Centre NHS Foundation Trust

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 10, 2025
• Study Start: January 15, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)