Clinical trial NCT03152136: A Pilot Study of the Cala ONE Device for Essential Tremor
Official title: A Pilot Study to Evaluate the Safety and Initial Effectiveness of the Cala ONE Device to Repeatably Aid in the Symptomatic Relief of Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Cala Health, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-12
Enrollment: 62
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first two weeks are a 3-arm parallel design (treatment, sham, and 'no intervention'). The second two weeks are open-label (all subjects cross-over to treatment arm).
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, randomized, controlled study designed to evaluate safety and repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized to the TAPS and sham arms will be blinded to their randomization assignments for the first two weeks of participation (controlled phase). After the first two weeks, all subjects will be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all subjects are to remain on a stable dosage of medications prescribed for the treatment of essential tremor, if applicable.


Eligibility criteria: Inclusion Criteria:

* Must be ≥22 and ≤80 years of age
* Competent and willing to provide written, informed consent to participate in the study
* A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
* Postural, action or intention tremor severity score of 2 or above in the dominant hand/arm as measured by the CRST rating scale
* Significant disability due to essential tremor (Bain \& Findley score of 3 or above in any one of the hand items)
* Currently or previously prescribed either propranolol or primidone for the treatment of essential tremor
* Stable dose of tremor medications for 30 days prior to study entry
* Stable dose of antidepressant medications for 90 days prior to study entry
* Willing to comply with study protocol requirements including: remaining on a stable dosage of tremor and antidepressant medications, if applicable, during the duration of the study; no significant alcohol or caffeine consumption within 12 hours of study visits; and no significant alcohol or caffeine consumption within 4 hours of twice-daily at home assessments during the controlled phase of the study

Exclusion Criteria:

* Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher)
* Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
* Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor
* Suspected or diagnosed epilepsy or other seizure disorder
* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
* Peripheral neuropathy affecting the tested upper extremity
* Presence of any other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
* Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
* Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
* Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
* Are participating or have participated in another Cala Health clinical trial
* Significant alcohol or caffeine consumption within 12 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
* Subjects unable to communicate with the investigator and staff
* Any health condition that in the investigator's opinion should preclude participation in this study
* Pregnancy or anticipated pregnancy during the course of the study

Primary outcomes:
measure: Percent Change in Tremor Power
timeFrame: Mean tremor power pre stimulation over two weeks of device usage as compared to mean tremor power post stimulation over two weeks of device usage.
Secondary outcomes:
Other outcomes:
measure: Change in Clinical Rating Scale for Tremor (CRST) After Stimulation
timeFrame: Collected before and after in-office stimulation sessions at Week 2
measure: Change in Clinical Global Impression of Severity (CGI-S)
timeFrame: Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4
measure: Change in Bain & Findley Activities of Daily Living (ADL) Scale
timeFrame: Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4. Collected via phone call Week 1 and Week 3.
measure: Subject Impression of Durability of Effect
timeFrame: Week 1, 2, 3 and 4.
measure: Change in Quality of Life in Essential Tremor Questionnaire (QUEST)
timeFrame: Week 0, 2, and 4
measure: Change in Patient Global Impression of Severity (PGI-S)
timeFrame: Before and after every stimulation session for TAPS and sham subjects through study completion. Twice daily for 'no intervention' subjects through study completion.
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4
measure: Subject Survey of Satisfaction
timeFrame: Week 4
measure: Device Usage Metrics
timeFrame: Week 4
measure: Change in Clinical Rating Scale for Tremor (CRST) After Stimulation
timeFrame: Collected before and after in-office stimulation sessions at Week 0 and 4.
measure: Change in Clinical Rating Scale for Tremor (CRST) During Stimulation
timeFrame: Collected before and during in-office stimulation sessions at Week 0, 2 and 4.
Locations:
city: Oakland
country: United States
facility: Personal Care Neurology
state: California
city: Denver
country: United States
facility: Movement & Neuroperformance Center
state: Colorado
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Kirkland
country: United States
facility: EvergreenHealth
state: Washington
Study officials:
References: