Trial Outcomes & Findings for Cala ONE Device for Essential Tremor (NCT NCT02629614)

NCT ID: NCT02629614

Last Updated: 2023-07-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: Immediately before and after 40 minute stimulation session
• Results posted on: 2023-07-18

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	48	45
Overall Study COMPLETED	48	44
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cala ONE Device for Essential Tremor

Baseline characteristics by cohort

Measure	TAPS Stimulation n=48 Participants 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.	Sham Stimulation n=45 Participants 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.	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Age, Continuous	70.5 years STANDARD_DEVIATION 11.2 • n=5 Participants	69.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	70.2 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	41 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in TETRAS Spiral Rating After Stimulation Baseline	2.95 score on a scale Standard Deviation 0.68	2.63 score on a scale Standard Deviation 0.52
Change in TETRAS Spiral Rating After Stimulation Post Stimulation	2.41 score on a scale Standard Deviation 1	2.23 score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Immediately before and 30 minutes into stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in TETRAS Spiral Rating During Stimulation Baseline	2.95 score on a scale Standard Deviation 0.68	2.63 score on a scale Standard Deviation 0.52
Change in TETRAS Spiral Rating During Stimulation During Stimulation	2.58 score on a scale Standard Deviation 0.90	2.26 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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).

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Self-report Improvement	35 Participants	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Kinetic Tremor Baseline	2.29 score on a scale Standard Deviation 0.47	2.27 score on a scale Standard Deviation 0.47
Change in Kinetic Tremor Change after stimulation	-0.53 score on a scale Standard Deviation 0.59	-0.34 score on a scale Standard Deviation 0.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and 30 minutes into stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Kinetic Tremor Baseline	2.29 score on a scale Standard Deviation 0.47	2.27 score on a scale Standard Deviation 0.47
Change in Kinetic Tremor Change during stimulation	-0.50 score on a scale Standard Deviation 0.51	-0.53 score on a scale Standard Deviation 0.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Lateral "Wing Beating" Postural Tremor Baseline	2.29 score on a scale Standard Deviation 0.70	2.16 score on a scale Standard Deviation 0.57
Change in Lateral "Wing Beating" Postural Tremor Change after stimulation	-0.56 score on a scale Standard Deviation 0.72	-0.36 score on a scale Standard Deviation 0.54

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and 30 minutes into stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Lateral "Wing Beating" Postural Tremor Baseline	2.29 score on a scale Standard Deviation 0.70	2.16 score on a scale Standard Deviation 0.57
Change in Lateral "Wing Beating" Postural Tremor Change during stimulation	-0.51 score on a scale Standard Deviation 0.70	-0.34 score on a scale Standard Deviation 0.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Forward Outstretched Postural Tremor Baseline	1.96 score on a scale Standard Deviation 0.54	1.91 score on a scale Standard Deviation 0.54
Change in Forward Outstretched Postural Tremor Change after stimulation	-0.75 score on a scale Standard Deviation 0.65	-0.35 score on a scale Standard Deviation 0.51

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and 30 minutes into stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Forward Outstretched Postural Tremor Baseline	1.96 score on a scale Standard Deviation 0.54	1.91 score on a scale Standard Deviation 0.54
Change in Forward Outstretched Postural Tremor Change during stimulation	-0.56 score on a scale Standard Deviation 0.59	-0.35 score on a scale Standard Deviation 0.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Bain & Findley ADL: Use a Spoon to Drink Liquid Baseline	3.18 score on a scale Standard Deviation 0.78	3.00 score on a scale Standard Deviation 0.85
Change in Bain & Findley ADL: Use a Spoon to Drink Liquid Change after stimulation	-0.78 score on a scale Standard Deviation 0.89	-0.59 score on a scale Standard Deviation 0.76

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Bain & Findley ADL: Hold a Cup of Liquid Baseline	2.95 score on a scale Standard Deviation 0.85	2.65 score on a scale Standard Deviation 0.92
Change in Bain & Findley ADL: Hold a Cup of Liquid Change after stimulation	-1.03 score on a scale Standard Deviation 0.73	-0.57 score on a scale Standard Deviation 0.80

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Bain & Findley ADL: Pouring Change after stimulation	-0.70 score on a scale Standard Deviation 0.76	-0.59 score on a scale Standard Deviation 0.72
Change in Bain & Findley ADL: Pouring Baseline	2.78 score on a scale Standard Deviation 1.03	2.59 score on a scale Standard Deviation 0.86

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Bain & Findley ADL: Dialing Baseline	2.23 score on a scale Standard Deviation 0.89	2.00 score on a scale Standard Deviation 0.91
Change in Bain & Findley ADL: Dialing Change after stimulation	-0.70 score on a scale Standard Deviation 0.79	-0.30 score on a scale Standard Deviation 0.62

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Bain & Findley ADL: Picking up Change Baseline	2.03 score on a scale Standard Deviation 0.86	1.92 score on a scale Standard Deviation 0.89
Change in Bain & Findley ADL: Picking up Change Change after stimulation	-0.53 score on a scale Standard Deviation 0.68	-0.05 score on a scale Standard Deviation 0.62

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Bain & Findley ADL: Inserting Plug Into Socket Change after stimulation	-0.33 score on a scale Standard Deviation 0.69	-0.24 score on a scale Standard Deviation 0.55
Change in Bain & Findley ADL: Inserting Plug Into Socket Baseline	1.83 score on a scale Standard Deviation 0.78	1.76 score on a scale Standard Deviation 0.80

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately before and after 40 minute stimulation session

Population: 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.

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.

Outcome measures

Measure	TAPS Stimulation n=40 Participants 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.	Sham Stimulation n=37 Participants 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.
Change in Bain & Findley ADL: Unlocking Baseline	2.23 score on a scale Standard Deviation 0.86	1.86 score on a scale Standard Deviation 0.67
Change in Bain & Findley ADL: Unlocking Change after stimulation	-0.60 score on a scale Standard Deviation 0.87	-0.16 score on a scale Standard Deviation 0.55

Adverse Events

TAPS Stimulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham Stimulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TAPS Stimulation n=48 participants at risk 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.	Sham Stimulation n=45 participants at risk 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.
Skin and subcutaneous tissue disorders Skin Irritation	4.2% 2/48	0.00% 0/45
Nervous system disorders Feeling of weakness around the wrist	2.1% 1/48	0.00% 0/45
Skin and subcutaneous tissue disorders Stinging pain in wrist	0.00% 0/48	2.2% 1/45

Additional Information

Sr. Director of Clinical Operations

Cala Health

Phone: 6506515296

Email: vivien@calahealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place