Trial Outcomes & Findings for Prospective Study for Symptomatic Relief of ET With Cala Therapy (NCT NCT03597100)

Last Updated: 2023-10-12

Results Overview

Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) subset score: TETRAS subset score relevant to the stimulated upper limb. The subset score is the sum of 6 rated tasks. Each task is rated 0 to 4, where a higher score indicates more severe tremor. Minimum subset score = 0; Maximum subset score = 24.

Recruitment status

COMPLETED

Study phase

Target enrollment

263 participants

Primary outcome timeframe

Baseline to 3-months

Results posted on

2023-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Cala TWO Two 40-minute stimulation sessions daily, separated by at least two hours Cala TWO: Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
Overall Study STARTED	263
Overall Study COMPLETED	205
Overall Study NOT COMPLETED	58

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Study for Symptomatic Relief of ET With Cala Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cala TWO n=263 Participants Two 40-minute stimulation sessions daily, separated by at least two hours Cala TWO: Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
Age, Continuous	69.6 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	253 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	237 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	263 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3-months

Outcome measures

Outcome measures
Measure	Cala TWO n=205 Participants Two 40-minute stimulation sessions daily, separated by at least two hours Cala TWO: Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score Baseline	12.6 score on a scale Standard Deviation 2.7
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score Final Visit	9.8 score on a scale Standard Deviation 3.5
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score Change	-2.8 score on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: Baseline to 3-months

Bain \& Findley ADL subset score relevant to the stimulated upper limb. The subset score is the sum of 8 rated tasks. Each task is rated 1 to 4, where a higher score indicates more severe tremor. Minimum subset score = 8; Maximum subset score = 32.

Outcome measures

Outcome measures
Measure	Cala TWO n=205 Participants Two 40-minute stimulation sessions daily, separated by at least two hours Cala TWO: Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score Baseline	18.4 score on a scale Standard Deviation 3.8
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score Final Visit	13.4 score on a scale Standard Deviation 4.4
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score Change	-4.98 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Average change in tremor power over 3-month study period

Subjects will be prompted to perform a postural hold task before and after each stimulation session. During this task, the device will record kinematic data using on-board motion sensors to objectively assess if there are any changes in tremor level. The change in each patient's pre- and post-stimulation tremor power was defined as the median change over all valid stimulation sessions. Sample mean and standard deviations were computed using the median change value from all patients.

Outcome measures

Outcome measures
Measure	Cala TWO n=193 Participants Two 40-minute stimulation sessions daily, separated by at least two hours Cala TWO: Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions	-0.8 (m/s^2)^2 Standard Deviation 3.7

Adverse Events

Cala TWO

Serious events: 5 serious events

Other events: 47 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cala TWO n=263 participants at risk Two 40-minute stimulation sessions daily, separated by at least two hours Cala TWO: Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
General disorders Initial or prolonged hospitalization	1.9% 5/263 • Number of events 6 • Up to 3 months since baseline testing

Other adverse events

Other adverse events
Measure	Cala TWO n=263 participants at risk Two 40-minute stimulation sessions daily, separated by at least two hours Cala TWO: Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
Skin and subcutaneous tissue disorders Significant and persistent skin irritation	5.3% 14/263 • Number of events 15 • Up to 3 months since baseline testing
Skin and subcutaneous tissue disorders Sore/Lesion	3.8% 10/263 • Number of events 11 • Up to 3 months since baseline testing
Skin and subcutaneous tissue disorders Significant discomfort	2.3% 6/263 • Number of events 7 • Up to 3 months since baseline testing
Skin and subcutaneous tissue disorders Electrical burns	2.3% 6/263 • Number of events 6 • Up to 3 months since baseline testing
Skin and subcutaneous tissue disorders Minor Skin Irritation	2.3% 6/263 • Number of events 6 • Up to 3 months since baseline testing
Skin and subcutaneous tissue disorders Electric shock sensation while using device	1.1% 3/263 • Number of events 3 • Up to 3 months since baseline testing
Nervous system disorders Worsening of tremor	0.76% 2/263 • Number of events 2 • Up to 3 months since baseline testing
Skin and subcutaneous tissue disorders Other isolated events	1.9% 5/263 • Number of events 6 • Up to 3 months since baseline testing

Additional Information

Sr. Director of Clinical Operations

Cala Health

Phone: 6506515296

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place