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Nerve Root Block in Spasticity

NCT06868342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-03-17

No results posted yet for this study

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

Interventions

PROCEDURE

High-frequency nerve conduction block

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.

Sponsors & Collaborators

  • Nevro Corp

    collaborator INDUSTRY

  • Walton Centre NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew Marshall, PhD · Walton Centre NHS Foundation Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-12-09
Completion
2024-12-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06868342 on ClinicalTrials.gov