Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study

Abstract

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.

Dispositivos tecnológicos para la supresión del temblor

“…terapia se pueden observar hasta cuatros horas de mejoría en el temblor 68 . Sin embargo, el efecto de la estimulación vibratoria sobre el temblor no ha demostrado un efecto consistente de reducción de la intensidad de temblor en pacientes con TE 69 .…”

“…Sin embargo, el efecto de la estimulación vibratoria sobre el temblor no ha demostrado un efecto consistente de reducción de la intensidad de temblor en pacientes con TE 69 . La escasez de estudios de eficacia de estos dos dispositivos y otros abordajes similares 67,68,70,71 , sumada a la ausencia de reducción de temblor descrita 69 , generan controversia sobre sus beneficios reales en temblor. Además, se desconocen estudios de eficacia de los movimientos giroscópicos sobre el temblor, por lo que se requieren futuros estudios que corroboren el efecto beneficioso de estos dispositivos.…”

4D printing of soft orthoses for tremor suppression

“…However, cooling or warming the limb had no effect on tremors in the upper limb [28]. In addition, vibration therapy has been tested on ET and PD patients, and devices like the Vilim ball (various frequencies from 8 to 18 Hz and 0-2 mm amplitude) work based on vibration therapy [30]. It was further indicated that mechanical vibration with a frequency between 50 and 450 Hz could not reduce hand tremors for ET [31].…”

A Review of Techniques Used to Suppress Tremor

“…Generally, classifying tremor levels based on frequency falls within the range of 4 to 18 Hz [1]. Tremors can be classified according to whether they happen at rest, the action, or with a particular posture of a patient [4]. Essential and Parkinson's tremors are the most common types in the world [5].…”