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

CompletedNot a drug-phase studyMS (type not specified)NCT06868342

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • High-frequency nerve conduction block

What it measured

Main measures

  • EMG - Nerve conduction block

    Intraoperative.

  • EMG - The reversibility of nerve conduction block

    Intraoperative.

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

    Intraoperative

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

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

Exclusion criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jan 2024

    2. Main results due

      Dec 2024

    3. Finished

      Dec 2024

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