Session Type: Abstract Submissions (ACR)
Background/Purpose: NeuroPoint is a medical device designed to provide noninvasive brain stimulation using a proprietary approach to deliver very low energy levels to deep brain structures. NeuroPoint provides a therapy referred to as “reduced impedance noninvasive cortical electrostimulation” (RINCE). An initial feasibility study of 77 patients diagnosed with fibromyalgia (FM) was conducted between 2006 and 2008. The current pilot study was designed to further evaluate the safety and efficacy of RINCE therapy in the treatment of FM.
A total of 46 patients selected using the ACR 1990 FM criteria were enrolled in a single site, 12-week, double-blind, sham-controlled trial. Patients were randomized (1:1:1) to receive 24, 16 or 0 RINCE stimulations over a 12 week period. Due to an additional, unintended 60 Hz stimulation signal that was originally present in the system, 8 of 15 patients randomized to 0 treatments (Sham) received a form of stimulation. The final disposition was:
Group/ # Treatments # Patients
A 24 15
B 16 16
C 0 7
Outcome measures included a 24-hour and 7-day recall pain VAS, Fibromyalgia Impact Questionnaire (FIQ-R), Patient Global Impression of Change (PGIC), and assessment of sleep, mood and neurocognitive changes.
Completion rates were excellent with 45 of 46 patients completing all 12 weeks of scheduled treatments. At the 3 month landmark endpoint, patients treated with 24 RINCE stimulations were statistically improved on VAS pain relative to the sham group (MMRM LS Mean change from baseline -31.8 vs -8.3 mm, p=0.009). Pain responder analyses, defining a responder as 50% improvement from baseline, also favored RINCE but did not reach statistical significance due to small numbers (5 of 15 vs 1 of 7, p=NS). Likewise, PGIC responder analyses where a responder is defined as “Much Improved” and “Very Much Improved”, also favored RINCE (8 of 15 vs 1 of 7, NS). Additional outcome measures generally favored RINCE as well: 7 day pain recall (VAS MMRM LS Mean contrast -22.9, p=0.013); FIQ-R total score (-24.5 vs -13.6, p=0.11); Neurocognitive functioning—MASQ improvement: -8.64 vs +2.43 (p=0.083); MCS cognition: -8.37 vs +0.09 (p=0.10); MCS mental clutter: -12.90 vs +0.44 (p=0.005). In addition, the Beck Depression Inventory and a modified Jenkins sleep questionnaire both numerically favored RINCE, but did not achieve statistical significance. Consistent with classification as a “non-significant risk” device, the adverse event profile of RINCE was very encouraging. The most common adverse event reported as potentially related to therapy was headache, reported by 3 patients out of 39 who received some form of stimulation therapy (8%). All other event reports were at rates of no more than 2 patients (5%), and were consistent with the underlying fibromyalgia.
Conclusion: Despite the very small control group of 7 patients, the benefit/ risk ratio of RINCE therapy with NeuroPoint appears highly favorable. This pilot study encouraged the sponsor to initiate a large, well powered pivotal trial in fibromyalgia.
R. M. Gendreau,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/treatment-of-fibromyalgia-with-neurostimulation-a-randomized-double-blinded-sham-controlled-trial/