Trial Outcomes & Findings for A Pilot Study of the Cala ONE Device for Essential Tremor (NCT NCT03152136)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

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.

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	No Intervention Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.
Overall Study STARTED	32	15	15
Overall Study COMPLETED	29	15	14
Overall Study NOT COMPLETED	3	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of the Cala ONE Device for Essential Tremor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAPS n=32 Participants 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.	Sham n=15 Participants 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.	No Intervention n=15 Participants Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.	Total n=62 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 8 • n=93 Participants	66 years STANDARD_DEVIATION 11 • n=4 Participants	67 years STANDARD_DEVIATION 9 • n=27 Participants	67 years STANDARD_DEVIATION 9 • n=483 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	7 Participants n=4 Participants	6 Participants n=27 Participants	34 Participants n=483 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	8 Participants n=4 Participants	9 Participants n=27 Participants	28 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=93 Participants	15 Participants n=4 Participants	15 Participants n=27 Participants	61 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants	15 Participants n=4 Participants	15 Participants n=27 Participants	60 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	32 participants n=93 Participants	15 participants n=4 Participants	15 participants n=27 Participants	62 participants n=483 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TAPS n=29 Participants 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.	Sham n=14 Participants 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.
Percent Change in Tremor Power	43 percent tremor improvement Standard Deviation 4	9 percent tremor improvement Standard Deviation 10

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected before and after in-office stimulation sessions at Week 2

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4

For TAPS and sham arms, the blinded rating neurologist will assess improvements in tremor level during and after stimulation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1, 2, 3 and 4.

TAPS and sham arms will also be asked how long their tremor relief lasts due to stimulation, if applicable.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 0, 2, and 4

The QUEST assessment will be administered to all subjects during in-office visits (every 2 weeks).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Before and after every stimulation session for TAPS and sham subjects through study completion. Twice daily for 'no intervention' subjects through study completion.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4

For TAPS and sham arms, the blinded subject will assess improvements in their tremor level during and after stimulation during office visits.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected before and after in-office stimulation sessions at Week 0 and 4.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected before and during in-office stimulation sessions at Week 0, 2 and 4.

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.

Outcome measures

Outcome data not reported

Adverse Events

TAPS

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

No Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TAPS n=32 participants at risk 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.	Sham n=15 participants at risk 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.	No Intervention n=15 participants at risk Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.
Skin and subcutaneous tissue disorders Skin irritation	3.1% 1/32 • Number of events 1 • 1 month	0.00% 0/15 • 1 month	0.00% 0/15 • 1 month
Skin and subcutaneous tissue disorders Discomfort	12.5% 4/32 • Number of events 4 • 1 month	6.7% 1/15 • Number of events 1 • 1 month	6.7% 1/15 • Number of events 1 • 1 month

Additional Information

Paula Chidester

Cala Health

Phone: 650-273-7436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60