Parkinson DiseaseNCT05012579
Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor
A study testing Cala Device in people with Parkinson Disease, run by Cala Health, Inc. at 1 site in United States.
Trial summary
Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cala Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥22 years of age
- Competent and willing to provide written, informed consent to participate in the study
- Clinically significant postural tremor as defined by:
- Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score
- Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry
- Willing to comply with study protocol requirements including:
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- Having the ability to do telemedicine or video calls for study visits
- remaining on a stable dosage of Parkinson's medications, if applicable, during the duration of the study
- no significant caffeine consumption within 8 hours of study visits
Who cannot join
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other seizure disorder
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- Peripheral neuropathy affecting the tested upper extremity
- Presence of any other neurodegenerative disease or dementia. These may include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
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- Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
- Significant caffeine consumption within 8 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee).
- Subjects unable to communicate with the investigator and staff
- Any health condition that in the investigator's opinion should preclude participation in this study
- Pregnancy or anticipated pregnancy during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD)
Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor
Read the detailed description
40 patients with PD with at least mild postural tremor were enrolled in a four-week, prospective, single-arm, open-label study of twice daily TAPS therapy. Due to the COVID-19 pandemic, TAPS devices were shipped to patients to run the study remotely. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.
- Conditions
- Parkinson Disease
- Being tested
- Cala Device
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cala DeviceDevice
transcutaneous afferent patterned stimulation (TAPS)
| Study group | Role | What they receive |
|---|---|---|
| TAPS delivered by Cala device | Experimental | Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Receives: Device: Cala Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor Power
Pre-specified effectiveness endpoints included improvements in (1) objective postural tremor power (primary outcome; assessed using an accelerometer on the device under standard of care medication state at home).
Measured: 4 weeks
Secondary outcomes (3)
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Improvement of clinician-ratings of Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) Part III [Goetz, C.G. et al. Wiley Intersci. 2008] (co-secondary; in medication-off state). Clinician rated patients' tremor pre and post therapy on a scale of 0-4. 0=Normal (no tremor), 4=Severe.
Measured: 4 weeks
Bain and Findley Activities of Daily Living (BF-ADL)
Improvement of patient-ratings of the Bain and Findley Activities of Daily Living (BF-ADL) [Bain PG, et al. Journal of Neurol, Neuros \& Psych 1993] (co-secondary; in medication-off state). Patients' rated ability to perform specific activities pre and post therapy on a scale from 1-4. 1=Able to do the activity without difficulty, 4=Cannot do the activity by yourself.
Measured: 4 weeks
Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I)
Clinician and Patient global impressions of improvement (CGI-I, PGI-I; exploratory) post therapy. This is a rated scale from 1-7, with 1=Very Much Improved to 7=Very Much Worse. Percentage of patients with ratings < 4 (including very much improved, much improved and improved) were computed respectively for CGI-I and PGI-I.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start11 Nov 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cala Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012579
- Sponsor's protocol ID
- PD-02
- Status last verified
- Jan 2024
- First submitted
- 3 Aug 2021
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT05012579
- Acronym / sponsor ID
- PD-02
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cala Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor
Detailed description
40 patients with PD with at least mild postural tremor were enrolled in a four-week, prospective, single-arm, open-label study of twice daily TAPS therapy. Due to the COVID-19 pandemic, TAPS devices were shipped to patients to run the study remotely. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAPS delivered by Cala device | Experimental | Device: Cala DeviceTwo 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be ≥22 years of age
- Competent and willing to provide written, informed consent to participate in the study
- Clinically significant postural tremor as defined by:
- Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry
- Willing to comply with study protocol requirements including:
Key exclusion criteria (11 listed)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- Suspected or diagnosed epilepsy or other seizure disorder
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- Peripheral neuropathy affecting the tested upper extremity
- Presence of any other neurodegenerative disease or dementia. These may include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cala Devicetranscutaneous afferent patterned stimulation (TAPS) | Device | TAPS delivered by Cala device |
Primary outcome
Tremor Power
Time frame: 4 weeks
Pre-specified effectiveness endpoints included improvements in (1) objective postural tremor power (primary outcome; assessed using an accelerometer on the device under standard of care medication state at home).
3 secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 4 weeks
Bain and Findley Activities of Daily Living (BF-ADL)
Time frame: 4 weeks
Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cala Device in people with Parkinson Disease, run by Cala Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor Power (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.