Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAPS | Experimental | Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation. |
|
| Sham | Sham Comparator | Subjects will receive a Cala ONE device that delivers sham stimulation. |
|
| No Intervention | No Intervention | Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cala ONE device | Device | The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Personal Care Neurology | Oakland | California | 94611 | United States | ||
| Movement & Neuroperformance Center |
Data will be published, but no PHI will be made available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TAPS | Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation. Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. |
| FG001 | Sham | Subjects will receive a Cala ONE device that delivers sham stimulation. Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. |
| FG002 | No Intervention | Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TAPS | Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation. Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. |
| BG001 | Sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percent tremor improvement | 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. |
|
1 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAPS | Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation. Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula Chidester | Cala Health | 650-273-7436 | paula@calahealth.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2017 | Apr 8, 2019 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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).
Not provided
Not provided
The first two weeks of the study are double-blinded for the treatment and sham arms. The subjects and rating movement disorder neurologists will be blinded to the therapy allocation for the treatment and sham arms. The subjects in the 'no intervention' arm and their rating neurologists will not be blinded to their therapy allocation.
The last two weeks are open-label, and all subjects will be given the option to use the Cala ONE device.
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| Denver |
| Colorado |
| 80113 |
| United States |
| Kansas University Medical Center | Kansas City | Kansas | 66103 | United States |
| EvergreenHealth | Kirkland | Washington | 98034 | United States |
Subjects will receive a Cala ONE device that delivers sham stimulation. Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. |
| BG002 | No Intervention | Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sham |
Subjects will receive a Cala ONE device that delivers sham stimulation. Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. |
|
|
| Other Pre-specified | 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. | Not Posted | Collected before and after in-office stimulation sessions at Week 2 | Participants |
| Other Pre-specified | 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. | Not Posted | Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4 | Participants |
| Other Pre-specified | 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. | Not Posted | Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4 | Participants |
| Other Pre-specified | 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. | Not Posted | 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. | Participants |
| Other Pre-specified | 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. | Not Posted | Week 1, 2, 3 and 4. | Participants |
| Other Pre-specified | 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). | Not Posted | Week 0, 2, and 4 | Participants |
| Other Pre-specified | 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. | Not Posted | Before and after every stimulation session for TAPS and sham subjects through study completion. Twice daily for 'no intervention' subjects through study completion. | Participants |
| Other Pre-specified | 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. | Not Posted | Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4 | Participants |
| Other Pre-specified | 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. | Not Posted | Week 4 | Participants |
| Other Pre-specified | 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. | Not Posted | Week 4 | Participants |
| Other Pre-specified | 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. | Not Posted | Collected before and after in-office stimulation sessions at Week 0 and 4. | Participants |
| Other Pre-specified | 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. | Not Posted | Collected before and during in-office stimulation sessions at Week 0, 2 and 4. | Participants |
| 0 |
| 32 |
| 0 |
| 32 |
| 5 |
| 32 |
| EG001 | Sham | Subjects will receive a Cala ONE device that delivers sham stimulation. Cala ONE device: The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves. | 0 | 15 | 0 | 15 | 1 | 15 |
| EG002 | No Intervention | Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor. | 0 | 15 | 0 | 15 | 1 | 15 |
| Discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided