Noninvasive neuromodulation in essential tremor demonstrates relief in a sham‐controlled pilot trial

Lin, Peter; Ross, Erika; Chidester, Paula; Rosenbluth, Kathryn H.; Hamner, Samuel R.; Wong, S.H.; Sanger, Terence D.; Hallett, Mark; Delp, Scott L.

doi:10.1002/mds.27350

Cited by 38 publications

(62 citation statements)

References 8 publications

(14 reference statements)

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“…Although the primary endpoint was not met, multiple other endpoints were met. The primary endpoint was specified following a small randomized blinded pilot study that demonstrated a significant difference between treatment and sham measured by the TETRAS Archimedes spiral (24). In the current multisite study, the spirals were not statistically different between treatment and sham because both were significantly improved from baseline.…”

Section: Safetymentioning

confidence: 86%

“…Lin et al recently reported reductions in hand tremor following noninvasive median and radial nerve stimulation in a small cohort of individuals with ET evaluated at a single site . In the current study, we investigated the effect of noninvasive median and radial nerve stimulation in a larger cohort of subjects in a prospective, randomized, sham controlled trial to further assess the safety and effectiveness of a wrist‐worn peripheral nerve stimulation device for treatment of hand tremors in adults with ET.…”

Section: Introductionmentioning

confidence: 94%

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An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor

Pahwa

Dhall

Ostrem

et al. 2019

Neuromodulation: Technology at the Neural Interface

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Objective To evaluate the safety and effectiveness of a wrist‐worn peripheral nerve stimulation device in patients with essential tremor (ET) in a single in‐office session. Methods This was a randomized controlled study of 77 ET patients who received either treatment stimulation (N = 40) or sham stimulation (N = 37) on the wrist of the hand with more severe tremor. Tremor was evaluated before and immediately after the end of a single 40‐minute stimulation session. The primary endpoint compared spiral drawing in the stimulated hand using the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Archimedes spiral scores in treatment and sham groups. Additional endpoints included TETRAS upper limb tremor scores, subject‐rated tasks from the Bain and Findley activities of daily living (ADL) scale before and after stimulation as well as clinical global impression‐improvement (CGI‐I) rating after stimulation. Results Subjects who received peripheral nerve stimulation did not show significantly larger improvement in the Archimedes spiral task compared to sham but did show significantly greater improvement in upper limb TETRAS tremor scores (p = 0.017) compared to sham. Subject‐rated improvements in ADLs were significantly greater with treatment (49% reduction) than with sham (27% reduction; p = 0.001). A greater percentage of ET patients (88%) reported improvement in the stimulation group as compared to the sham group (62%) according to CGI‐I ratings (p = 0.019). No significant adverse events were reported; 3% of subjects experienced mild adverse events. Conclusions Peripheral nerve stimulation in ET may provide a safe, well‐tolerated, and effective treatment for transient relief of hand tremor symptoms.

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Section: Safetymentioning

confidence: 86%

Section: Introductionmentioning

confidence: 94%

An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor

Pahwa

Dhall

Ostrem

et al. 2019

Neuromodulation: Technology at the Neural Interface

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“…As a result, it is possible that the current EEG findings capture this effect in parietal and sensorimotor cortex. A recent study found that cooling the limb reduced ET amplitude, and an additional study found that stimulating nerves in the wrist reduced essential tremor amplitude . Thus, feedback from peripheral receptors may be important, although not measured directly in the current study.…”

Section: Discussionmentioning

confidence: 99%

Cortical dynamics within and between parietal and motor cortex in essential tremor

et al. 2018

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Background Evidence from functional imaging in essential tremor suggests that activity within parietal and motor cortices may be associated with worsening of tremor at increased visual feedback. Objectives Examine how cortical oscillations within these regions and the connectivity between these regions is associated with worsening of tremor in essential tremor in response to high visual feedback. Method The study included 24 essential tremor participants and 17 controls. We measured cortical activity and tremor magnitude at low and high feedback conditions. Cortical activity was measured using high‐density electroencephalogram and isolated using source localization. Results Changes in power across feedback in the 4–12 Hz and 12–30 Hz bands were reduced within the contralateral motor cortex of essential tremor patients compared to controls. The 12–30 Hz bidirectional connectivity between the parietal and contralateral motor cortex was decreased in essential tremor patients. Worsening of tremor from low to high visual feedback was associated with 4–12 Hz activity in contralateral motor cortex. The greatest separation between groups was found when using the difference of the contralateral motor cortex activity at high and low feedback, rather than either feedback condition alone. Conclusion Our findings provide new evidence that tremor in essential tremor is associated with reduced power across feedback in the motor cortex and reduced connectivity between the parietal and motor cortices. Combined with previous work on the cerebellar‐thalamo‐cortical motor circuit, our findings suggest that the network level disturbances associated with essential tremor extend to the cortico‐cortical pathway between the parietal cortex and motor cortex. © 2018 International Parkinson and Movement Disorder Society

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“…A pilot randomized sham-controlled pilot trial was conducted to see if local vibration is effective in patients with essential tremor. The pilot study revealed promising results, as the motor performance, evaluated with the Archimedes spiral drawing task, improved after stimulation, when compared against baseline [ 12 ]. This research (with the same device) was followed with a pivotal study, where it was shown that subjects who received peripheral nerve stimulation did not show a significantly larger improvement in the Archimedes spiral task compared to sham but did show a significantly greater improvement in upper limb TETRAS tremor scores ( p = 0.017) compared to sham.…”

Section: Discussionmentioning

confidence: 99%

“…Medical device development for the ET patients is afoot [ 11 ]. Non-invasive neuromodulation through ulnar and radial nerve stimulation was shown to be effective and had a favorable safety profile in the ET patients in a sham-controlled clinical trial [ 12 ]. Transcranial magnetic stimulation is also being explored as a treatment option in the aforementioned patient population [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study

et al. 2020

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Background and objectives: tremor is an unintentional and rhythmic movement of any part of the body that is a typical symptom of Essential Tremor (ET). ET impairs the quality of life of patients and is treated with pharmacotherapy. We investigated the tremor reduction efficacy of an innovative vibrational medical device (IMD) in ET patients. Materials and Methods: we conducted a prospective, single-center, single-arm, pragmatic study in ET patients with an extended safety study to evaluate the efficacy and safety of the Vilim Ball—a local hand-arm vibration device that produces vibrations in the frequency range of 8–18 Hz and amplitude from 0 to 2 mm. The primary endpoint was the decrease in the power spectrum after device use. The secondary endpoints were safety outcomes. Results: In total, 17 patients with ET were included in the main study, and no patients withdrew from the main study. The tremor power spectrum (m2/s3 Hz) was lower after the device use, represented as the mean (standard deviation): 0.106 (0.221); median (Md) 0.009 with the interquartile range; IQR, 0.087 vs. 0.042 (0.078); Md = 0.009 with the IQR 0.012; Wilcoxon signed-rank test V = 123; and p = 0.027. Seven patients reported that vibrational therapy was not effective. Two patients reported an increase in tremor after using the device. In the extended safety study, we included 51 patients: 31 patients with ET and 20 with Parkinsonian tremor, where 48 patients reported an improvement in tremor symptoms and 49 in function. No serious adverse events were reported, while two patients in the Parkinsonian tremor group reported a lack of efficacy of the proposed medical device. Conclusions: the device reduces essential tremor in some patients and is safe to use in ET.

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Noninvasive neuromodulation in essential tremor demonstrates relief in a sham‐controlled pilot trial

Cited by 38 publications

References 8 publications

An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor

An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor

Cortical dynamics within and between parietal and motor cortex in essential tremor

Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study

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