Insula Neuromodulation for Chronic Neuropathic Pain

Status Recruiting

Clinical Trial Summary

This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.

Clinical Trial Description

In the first stage, 12 subjects with refractory neuropathic pain will be enrolled to an inpatient clinical trial for insular brain mapping with acute stimulation and neurophysiological brain monitoring. Electrodes for stimulation and recording will be implanted stereotactically along the anterior-posterior axis of the insular cortex. 'Responders' to trial stimulation and the optimal region of the insula for pain relief will be identified during this inpatient stage. 'Responder' subjects who have positive analgesic effects from acute insular stimulation during the first stage will continue to the second stage. The second stage, clinical trial is conducted outpatient and will test chronic deep brain stimulation of the insula. The study design is randomized, sham-stimulation-controlled, double-blinded, and cross-over where subjects receive both active and sham stimulation. Furthermore, neurophysiological biomarkers of pain will be investigated by studying changes in neural activity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05404581
Study type	Interventional
Source	University of Virginia
Contact	Judy Beenhakker
Phone	434-982-1856
Email	jgb3p@hscmail.mcc.virginia.edu
Status	Recruiting
Phase	N/A
Start date	November 1, 2022
Completion date	June 30, 2027

View Details

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