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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: TAPS delivered by Cala device with Trio band | Experimental | Two 40-minute TAPS sessions daily for 14 days |
|
| Experimental: TAPS delivered by Cala device with Trio+ band | Experimental | Two 40-minute TAPS sessions daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cala Device | Device | transcutaneous afferent patterned stimulation (TAPS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, pre-intervention and immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, pre-intervention and immediately after the intervention |
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Inclusion Criteria:
For subjects with Essential Tremor:
For subjects with Parkinson's Disease:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cala Clinic | San Mateo | California | 94404 | United States |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
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| 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 | 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) | baseline, pre-intervention and immediately after the intervention |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |