At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Determination of Feasibility of Reversible Conduction Block Generated Using Peripheral Nerve Stimulator in Treatment of Focal Spasticity and the Stimulation Parameters for the Same.
In Brief
A clinical study evaluating High-frequency nerve conduction block for Spasticity and 3 related conditions. Completed, enrolled 4 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.