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This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAPS Stimulation | Experimental | Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. |
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| Sham Stimulation | Sham Comparator | 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cala ONE Device | Device | The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TETRAS Spiral Rating After Stimulation | The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and after 40 minute stimulation session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TETRAS Spiral Rating During Stimulation | An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kinetic Tremor | The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and after 40 minute stimulation session |
Inclusion Criteria:
Exclusion Criteria:
Subjects already taking medications for their essential tremor will remain on their medications during the study with no changes in medication type or dosage levels.
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| Name | Affiliation | Role |
|---|---|---|
| Lin, MD | Clinical Advisor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94121 | United States | ||
| The Parkinson's Institute |
Data will be published, but no PHI will be made available.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAPS Stimulation | Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. |
| FG001 | Sham Stimulation | 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TAPS Stimulation | Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in TETRAS Spiral Rating After Stimulation | The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAPS Stimulation | Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director of Clinical Operations | Cala Health | 6506515296 | vivien@calahealth.com |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Immediately before and 30 minutes into stimulation session |
| Self-report Improvement | The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse). | Immediately before and after 40 minute stimulation session |
| Change in Kinetic Tremor | The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and 30 minutes into stimulation session |
| Change in Lateral "Wing Beating" Postural Tremor | The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and after 40 minute stimulation session |
| Change in Lateral "Wing Beating" Postural Tremor | The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and 30 minutes into stimulation session |
| Change in Forward Outstretched Postural Tremor | The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and after 40 minute stimulation session |
| Change in Forward Outstretched Postural Tremor | The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and 30 minutes into stimulation session |
| Change in Bain & Findley ADL: Use a Spoon to Drink Liquid | The change in tremor severity on drinking liquid with a spoon as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Immediately before and after 40 minute stimulation session |
| Change in Bain & Findley ADL: Hold a Cup of Liquid | The change in tremor severity on holding a cup of liquid as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Immediately before and after 40 minute stimulation session |
| Change in Bain & Findley ADL: Pouring | The change in tremor severity on pouring as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Immediately before and after 40 minute stimulation session |
| Change in Bain & Findley ADL: Dialing | The change in tremor severity on dialing a telephone as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Immediately before and after 40 minute stimulation session |
| Change in Bain & Findley ADL: Picking up Change | The change in tremor severity on picking up change as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Immediately before and after 40 minute stimulation session |
| Change in Bain & Findley ADL: Inserting Plug Into Socket | The change in tremor severity on inserting a plug into a socket as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Immediately before and after 40 minute stimulation session |
| Change in Bain & Findley ADL: Unlocking | The change in tremor severity on unlocking a lock with a key as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Immediately before and after 40 minute stimulation session |
| Sunnyvale |
| California |
| 94085 |
| United States |
| Kansas University Medical Center | Kansas City | Kansas | 66103 | United States |
| Swedish Medical Center Seattle | Seattle | Washington | 98122 | United States |
| BG001 | Sham Stimulation | 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sham Stimulation | 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. |
|
|
| Secondary | Change in TETRAS Spiral Rating During Stimulation | An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 30 minutes into stimulation session |
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|
|
| Secondary | Self-report Improvement | The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse). | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Count of Participants | Participants | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Kinetic Tremor | The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Kinetic Tremor | The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 30 minutes into stimulation session |
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| Other Pre-specified | Change in Lateral "Wing Beating" Postural Tremor | The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Lateral "Wing Beating" Postural Tremor | The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 30 minutes into stimulation session |
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| Other Pre-specified | Change in Forward Outstretched Postural Tremor | The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Forward Outstretched Postural Tremor | The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 30 minutes into stimulation session |
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| Other Pre-specified | Change in Bain & Findley ADL: Use a Spoon to Drink Liquid | The change in tremor severity on drinking liquid with a spoon as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Bain & Findley ADL: Hold a Cup of Liquid | The change in tremor severity on holding a cup of liquid as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Bain & Findley ADL: Pouring | The change in tremor severity on pouring as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Bain & Findley ADL: Dialing | The change in tremor severity on dialing a telephone as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Bain & Findley ADL: Picking up Change | The change in tremor severity on picking up change as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Bain & Findley ADL: Inserting Plug Into Socket | The change in tremor severity on inserting a plug into a socket as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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| Other Pre-specified | Change in Bain & Findley ADL: Unlocking | The change in tremor severity on unlocking a lock with a key as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task. | Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and after 40 minute stimulation session |
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|
| 0 |
| 48 |
| 2 |
| 48 |
| EG001 | Sham Stimulation | 0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes. | 0 | 45 | 1 | 45 |
| Feeling of weakness around the wrist | Nervous system disorders |
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| Stinging pain in wrist | Skin and subcutaneous tissue disorders |
|
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