Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks.
20 patients with (13 with ET and 7 with PD) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. TAPS devices were shipped to patients to run the study remotely. In the first arm of the study, subjects received TAPS treatment using the original. Cala Trio band for two weeks. Followed by a wash-out period (\> 24 hours), subjects entered the second arm and received TAPS using the Trio+ band for an additional two weeks. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
transcutaneous afferent patterned stimulation (TAPS)
Cala Clinic
San Mateo, California, United States
Tremor power changes from pre-stimulation to post-stimulation
Tremor improvement was measured by Tremor Power Improvement Ratio (TPIR) using kinematic data collected by the device. The TPIR was calculated as pre-stimulation power divided by post-stimulation power, which was computed from device-collected accelerometer data
Time frame: baseline, pre-intervention and immediately after the intervention
Change in TETRAS from pre-stimulation to post- stimulation within each visit
For subjects with Essential Tremor only: Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) subset score, relevant to the stimulated upper limb, change from pre-stimulation to post- stimulation within each visit
Time frame: baseline, pre-intervention and immediately after the intervention
Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit
For subjects with Parkinson's Disease only: Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS) subset score, change from pre- stimulation to post-stimulation within each visit
Time frame: baseline, pre-intervention and immediately after the intervention
Change in BF-ADL
Change in the Bain \& Findley activities of daily living (BF-ADL) score from pre- to post-stimulation at each of the two study visits associated with the Trio and Trio+ bands (four study visits total)
Time frame: baseline, pre-intervention and immediately after the intervention
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