Objective: The objective was to carry out an in-clinic evaluation of a new body-worn bilateral Sensory Electrical Stimulation cueing system (Figure 1) designed to reduce Freezing of Gait (FoG) in both the OFF and ON states.

Background: Freezing of Gait (FoG) is a highly debilitating condition affecting persons with Parkinson’s disease (PD). FoG described as the sudden, unexpected loss of the ability to move your feet and walk, is one of the most problematic motor symptoms in PD, the fastest-growing neurological disorder in the world, with the number of persons with PD worldwide set to more than double between 2015 and 2040 [1]. FoG leads to an increased risk of falls [2], a significant reduction in quality of life [3], and a loss of independence. The current standard of care for FoG leaves a significant unmet need, and more effective and user-friendly solutions are urgently needed.

Method: A body-worn bilateral sensory electrical stimulation cueing system delivering cues to the anterior skin surface of the person’s left and right thighs in an alternating, rhythmic manner (Figures 1 & 2) was tested. The Stimulation Amplitude for each leg was set between the sensory and discomfort thresholds for that leg (Figures 3 & 4), and the cue rhythm was scaled to the patient’s un-cued stride rhythm. A patient with moderate FoG was tested using in-clinic FoG provocation tests under Baseline, Sham stimulation, and Active stimulation conditions when the patient was in both the ON and OFF states. The Percentage of Time in FoG (PTF) and Number of FoG episodes Occurring (NFO) were assessed using frame-by-frame video analysis by two blinded, independent expert raters. The mean values for both raters were used.

Results: The results are summarized in Table 1. In the OFF state, PTF was reduced from Baseline to Active by 78.54% and from Sham to Active by 77.2%. In the OFF state, NFO was reduced from Baseline to Active by 59.26% and from Sham to Active by 50.0%. In the ON-state, PTF was reduced from Baseline to Active by 73.84% and from Sham to Active by 23.46%. In the ON-state, NFO was reduced from Baseline to Active by 44.44% and from Sham to Active by 0.0%.

Conclusion: These initial single patient data are promising with a reduction in FoG observed in both the ON and OFF states. Electrical stimulation was well tolerated. Testing will continue.

Figure 1: Sensory Electrical Stimulation system

Figure 2: Rhythmic sensory electrical stimulation

Figure 3: Stimulation parameters

Figure 4: Thresholding Process

Table 1: PTF and NFO values and % reductions

References: [1] E. R. Dorsey, T. Sherer, M. S. Okun, and B. R. Bloem, “The Emerging Evidence of the Parkinson Pandemic,” J Parkinsons Dis, vol. 8, no. Suppl 1, pp. S3–S8, 2018, doi: 10.3233/JPD-181474.
[2] N. E. Allen, A. K. Schwarzel, and C. G. Canning, “Recurrent Falls in Parkinson’s Disease: A Systematic Review,” Parkinson’s Disease, vol. 2013, no. 1, p. 906274, 2013, doi: 10.1155/2013/906274.
[3] O. Moore, C. Peretz, and N. Giladi, “Freezing of gait affects quality of life of peoples with Parkinson’s disease beyond its relationships with mobility and gait,” Mov. Disord., vol. 22, no. 15, pp. 2192–2195, Nov. 2007, doi: 10.1002/mds.21659.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/initial-evaluation-of-a-body-worn-bilateral-sensory-electrical-stimulation-cueing-system-in-reducing-freezing-of-gait-fog-in-a-patient-in-the-off-and-on-states/