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Completed

NCT Number: NCT05012579

Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cala Clinic

Burlingame, California, 94010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Cala Device

Device

transcutaneous afferent patterned stimulation (TAPS)

Primary outcomes

  1. 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).

Secondary outcomes

  1. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Time frame: 4 weeks

    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.

  2. Bain and Findley Activities of Daily Living (BF-ADL)

    Time frame: 4 weeks

    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.

  3. Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I)

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cala Health, Inc.

Industry

Registry information

Official study title

A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2021
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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