A Pilot Study of the Cala ONE Device for Essential Tremor

Essential Tremor Clinical Trial

— EXCITE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152136
• Other study ID #: ET-13
• Status: Completed
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: March 8, 2018

Study information

• Verified date: April 2019
• Source: Cala Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• Cala ONE device
The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.

Locations

Country	Name	City	State
United States	Movement & Neuroperformance Center	Denver	Colorado
United States	Kansas University Medical Center	Kansas City	Kansas
United States	EvergreenHealth	Kirkland	Washington
United States	Personal Care Neurology	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Cala Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Clinical Rating Scale for Tremor (CRST) After Stimulation	A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated after stimulation.	Collected before and after in-office stimulation sessions at Week 2
Other	Change in Clinical Global Impression of Severity (CGI-S)	Tremor severity will be assessed with the 7-point CGI-S scale at baseline for all arms. For TAPS and sham arms, CGI-S will also be assessed during and after stimulation.	Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4
Other	Clinical Global Impression of Improvement (CGI-I)	For TAPS and sham arms, the blinded rating neurologist will assess improvements in tremor level during and after stimulation.	Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4
Other	Change in Bain & Findley Activities of Daily Living (ADL) Scale	The complete Bain & Findley ADL questionnaire will be administered at baseline for all arms. For TAPS and sham arms, a subset of ADLs relevant to upper limb tremor will be repeated with provided props during and after stimulation.; On a weekly basis, all subjects will answer the complete Bain & Findley ADL questionnaire via phone call.	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.
Other	Subject Impression of Durability of Effect	TAPS and sham arms will also be asked how long their tremor relief lasts due to stimulation, if applicable.	Week 1, 2, 3 and 4.
Other	Change in Quality of Life in Essential Tremor Questionnaire (QUEST)	The QUEST assessment will be administered to all subjects during in-office visits (every 2 weeks).	Week 0, 2, and 4
Other	Change in Patient Global Impression of Severity (PGI-S)	Tremor severity will be assessed with the 7-point PGI-S scale at baseline for all arms. For TAPS and sham arms, PGI-S will also be assessed during and after stimulation during office visits.; Additionally, for TAPS and sham arms, PGI-S will be entered on the device before and after each stimulation session in the home environment.	Before and after every stimulation session for TAPS and sham subjects through study completion. Twice daily for 'no intervention' subjects through study completion.
Other	Patient Global Impression of Improvement (PGI-I)	For TAPS and sham arms, the blinded subject will assess improvements in their tremor level during and after stimulation during office visits.	Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4
Other	Subject Survey of Satisfaction	At the final visit, all subject will take a subject satisfaction survey which will include questions such as likelihood to recommend and other questions related to the usability of the device.	Week 4
Other	Device Usage Metrics	For TAPS and sham arms, the device will record usage metrics such as how many times the device was used per day and stimulation amplitude, to assess if there are any changes over time within group and within subject.	Week 4
Other	Change in Clinical Rating Scale for Tremor (CRST) After Stimulation	A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated after stimulation.	Collected before and after in-office stimulation sessions at Week 0 and 4.
Other	Change in Clinical Rating Scale for Tremor (CRST) During Stimulation	A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated during stimulation.	Collected before and during in-office stimulation sessions at Week 0, 2 and 4.
Primary	Percent Change in Tremor Power	For TAPS and sham arms, subjects will be prompted to perform a lateral postural hold prior to entering their PGI-S score before and after each stimulation session. During this hold, the device will record motion data to objectively assess if there are any changes in tremor level.	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.