Abstract Details

Title Non-Invasive Brain Stimulation For Diabetic Neuropathic Pain

Topic Pain

Presentation(s) S9 - Neuromodulation and Alternatives to Reduce Opioid Use in Pain Management (1:36 PM-1:48 PM)

Poster/Presentation
Number 004

Background Current therapies do not address DNP’s central component. Conventional Non-Invasive Brain Stimulation (NIBS) has been effective in treating chronic pain, yet with limited efficacy on neuropathic pain. ESStim™ is an improved NIBS modality with enhanced focality, penetration, and targeting control, which has shown benefits in other chronic pain.

Objective Assess the therapeutic effects of Electrosonic Stimulation (ESStim™) in treating chronic Diabetic Neuropathic Pain (DNP).

Design/Methods

Single-center, double-blinded, placebo controlled, randomized study comparing Active to SHAM ESStim™ in 20 patients. Inclusion Criteria: presence of chronic DNP (involving at least one foot), which is resistant to first-line therapies, for at least six months with Visual Analog Score (VAS) Pain score 4.0 or greater on a 10-point scale. Exclusion criteria: unstable pain, history of epilepsy, structural brain lesions, substance abuse, and pregnancy.

20 patients were randomized (10 Active, 10 SHAM), and stimulation was provided for 5 sessions, 20 min/day, over a 1-week period. Assessments occurred at baseline, following stimulation, and at follow-ups 2-, 4-, and 6-weeks following stimulation. Assessments included: Quantitative Sensory Testing (QST), Safety, Biomechanical, Global Assessments, and Pain Questionnaires (VAS, VRS pain, MPI, BPI-DPN). Univariate analysis (e.g., ANOVA) was applied (p<0.05).

Results

Primary endpoint (VAS pain): Active ESStim showed a clinically and statistically significant improvement (2.2-point vs. SHAM’s 1.1-point reduction; and a 39 % reduction vs. 19% for SHAM averaged from the last treatment session through the last follow up). Clinically and statistically significant effects observed across pain questionnaires, quality of life assessments, QST, and biomechanical assessments. Concurrently, 30% Active patients demonstrated a reduced analgesic use vs. no changes in the SHAM group. There were no differences in safety measures between groups.

Conclusions

Our results suggest that ESStim™ is a safe and efficacious therapy for the treatment of chronic DNP.

Authors/Disclosures
Ciro Ramos Estebanez, MD, PhD, MBA, FAAN (University of Illinois in Chicago) PRESENTER	The institution of Dr. Ramos Estebanez has received research support from NIH. Dr. Ramos Estebanez has received intellectual property interests from a discovery or technology relating to health care.
Persen Sukpornchairak, MD (University Hospitals Cleveland Medical Center)	Dr. Sukpornchairak has nothing to disclose.
Krishnakant Shah Aka Khandelwal (University of Illinois at Chicago)	Mr. Shah Aka Khandelwal has nothing to disclose.
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Felipe Fregni (Spaulding Rehabilitation Hospital)	No disclosure on file
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