RecruitingNot Applicable

Insula Neuromodulation for Chronic Neuropathic Pain

United States12 participantsStarted 2022-11-01

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men and women, between 18 and 80 years, inclusive
✓. Subjects who are able and willing to give consent and able to attend all study visits
✓. The pain is:
✓. The pain is neuropathic or predominantly neuropathic if mixed components.
✓. Insula region must be apparent on MRI so that direct targeting can be performed for SEEG and DBS electrode placement.
✓. Able to communicate and report sensations during all stimulation testing
✓. Stable prescribed doses of all symptomatic pain medications for 30 days prior to study entry and for the duration of the study.

Adverse events

Timeframe: Entire study period from enrollment through 6 months post DBS implantation

Pain intensity

Timeframe: Baseline, 3 months post DBS stimulation, 3 months post sham stimulation

NCT IDNCT05404581

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Judy Beenhakker