An interventional study of Cala ONE device in Essential Tremor, sponsored by Cala Health, Inc.. Completed at 4 sites in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Cala Health, Inc. · Not applicable, Interventional, and Treatment
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.
257 studies on the registry are indexed under Tremor; 59 are open to participants now.
This study's enrollment of 62 is above the median of 25 across 184 interventional studies indexed under Tremor.
Browse Tremor studies →Cala Health, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
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Exclusion Criteria:
Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation.
Device: Cala ONE device
Subjects will receive a Cala ONE device that delivers sham stimulation.
Device: Cala ONE device
Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.
The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.
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.
Time frame: 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.
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.
Time frame: Collected before and after in-office stimulation sessions at Week 2
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.
Time frame: Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4
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.
Time frame: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4
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.
Time frame: 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.
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.
Time frame: Week 1, 2, 3 and 4.
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).
Time frame: Week 0, 2, and 4
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.
Time frame: Before and after every stimulation session for TAPS and sham subjects through study completion. Twice daily for 'no intervention' subjects through study completion.
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.
Time frame: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4
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.
Time frame: Week 4
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.
Time frame: Week 4
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.
Time frame: Collected before and after in-office stimulation sessions at Week 0 and 4.
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.
Time frame: Collected before and during in-office stimulation sessions at Week 0, 2 and 4.
| Milestone | TAPS | Sham | No Intervention |
|---|---|---|---|
| Started | 32 | 15 | 15 |
| Completed | 29 | 15 | 14 |
| Not completed | 3 | 0 | 1 |
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.
| percent tremor improvement | TAPS | Sham |
|---|---|---|
| Percent Change in Tremor Power | 43 ± 4 | 9 ± 10 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
For TAPS and sham arms, the blinded rating neurologist will assess improvements in tremor level during and after stimulation.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
TAPS and sham arms will also be asked how long their tremor relief lasts due to stimulation, if applicable.
Results for this outcome have not been posted.
The QUEST assessment will be administered to all subjects during in-office visits (every 2 weeks).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
For TAPS and sham arms, the blinded subject will assess improvements in their tremor level during and after stimulation during office visits.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TAPS | 0/32 (0%) | 0/32 (0%) | 5/32 (15.6%) |
| Sham | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| No Intervention | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Event | TAPS | Sham | No Intervention |
|---|---|---|---|
| DiscomfortSkin and subcutaneous tissue disorders | 4/32 | 1/15 | 1/15 |
| Skin irritationSkin and subcutaneous tissue disorders | 1/32 | 0/15 | 0/15 |
| Age, Continuous(years) | TAPS | Sham | No Intervention | Total |
|---|---|---|---|---|
| Mean | 67 ± 8 | 66 ± 11 | 67 ± 9 | 67 ± 9 |
| Sex: Female, Male(Participants) | TAPS | Sham | No Intervention | Total |
|---|---|---|---|---|
| Female | 21 | 7 | 6 | 34 |
| Male | 11 | 8 | 9 | 28 |
| Ethnicity (NIH/OMB)(Participants) | TAPS | Sham | No Intervention | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 31 | 15 | 15 | 61 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | TAPS | Sham | No Intervention | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 30 | 15 | 15 | 60 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | TAPS | Sham | No Intervention | Total |
|---|---|---|---|---|
| United States | 32 | 15 | 15 | 62 |
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Plan to share: No — Data will be published, but no PHI will be made available.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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