University of Virginia
This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.
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…
Inclusion Criteria: 1. Men and women, between 18 and 80 years, inclusive 2. Subjects who are able and willing to give consent and able to attend all study visits 3. The pain is: * chronic with ≥6 month duration * severe is defined as: 'average' NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months * disabling and has resulted in an inability to work or perform ADLs in the home * medication-refractory to adequate trials of at least 3 prescription medications (including at least one current or past opioi…
During the inpatient phase of the study, insular mapping will be performed with electrical stimulation to implanted SEEG electrodes in order to optimize the region for trial stimulation. Subjects who respond favorably to trial stimulation in the hospital, will progress to the outpatient clinical trial phase where a DBS system will be implanted. All subjects will be blindly randomized to 3 months of stimulation and 3 months of sham stimulation.
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