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NCT06868342Completed

Nerve Root Block in Spasticity

Determination of Feasibility of Reversible Conduction Block Generated Using Peripheral Nerve Stimulator in Treatment of Focal Spasticity and the Stimulation Parameters for the Same.

Source: ClinicalTrials.gov · Last updated 17 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
4 (actual)
First submitted
7 Mar 2025
Start date
15 Jan 2024
Primary completion date
9 Dec 2024
Lead sponsor
Walton Centre NHS Foundation Trust
NCT number
NCT06868342

What you commit to

  • Study type: Interventional
  • Participants enrolled: 4
  • From 15 Jan 2024 to the primary completion date, 9 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Myopathy and other LMN disorders

Age

  • Age \<18yr

Other

  • Impaired LMN pathway determined by EMG

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Walton Centre NHS Foundation Trust
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.