Skip to main content
OpenTrials
Completed

NCT Number: NCT06397391

Nonlinear Absorber in Essential Tremor Treatment

The goal of this study is to develop a non linear absorber for patients with essential tremor (ET). It 's an extern passive medical device which should improve patients tremor.

Investigators will evaluate the impact of this medical device through one clinical scale (Fahn-Tolosa-Marin) and accelerometry record. Investigators focus on motor improvement.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult man or woman between 20 and 90 years old
  • Diagnosis of ET (Essential Tremor) established by a neurologist
  • ET affecting the upper limbs, associated or not with head tremor
  • Drug-resistant nature of ET (failure of beta-blockers, mysoline, benzodiazepine)
  • Affiliate to a social security or similar system
  • Having given written consent to participate in the study, free and informed.

Exclusion criteria

  • Severe comorbidity
  • ET affecting only the leader
  • Wounds on the forearm
  • Modification of treatment or surgery to manage ET, planned within 3 months following inclusion
  • Cognitive disorder known or suspected by the investigator
  • Pregnant or breastfeeding woman
  • Persons placed under guardianship, curatorship or under judicial protection
  • Persons deprived of liberty, subject to psychiatric care or admitted to a health or social establishment for purposes other than that of clinical investigation

Criteria for premature discharge

  • MMSE (Mini-Mental State Examination) score<24;
  • ET of the patient with frequency range not between 4 to 6 Hz or 8 to 12 Hz and/or amplitudes of movement greater than 20°.
  • modification of treatment for ET or performance of tremor surgery before the final visit;
  • withdrawal of consent or refusal to continue visits.

Treatment and study plan

TREM-AB

Device

Wearing medical device on site during 1 hour

Primary outcomes

  1. Tremor improvement

    Time frame: 6 months maximum

    To assess tremor improvement, investigators will use the Fahn-Tolosa-Marin rating scale. This scale allows, thanks to a score, to assess clinical and functional evaluation of the tremor. Different aspect of the tremor are evaluate like the frequency of the tremor of the head, hand, arm..etc. and the impact of the tremor on daily actions (like writing, drawing, …).

    This score will be assessed at Visit 1 and 2. During visit 2, the assessment will be performed before and 1 hour after wearing the device.

Secondary outcomes

  1. Tremor frequency

    Time frame: 6 months maximum

    To assess tremor frequency, investigators will use accelerometry record and electromyography.

    This score will be assessed at Visit 1 and 2. During visit 2, the assessment will be performed before and 1 hour after wearing.the device.

  2. Tolerance to wearing the device

    Time frame: 6 months maximum

    Adverse reactions occurring during use of the device

  3. Patient satisfaction with the device measured by a specific multidimensional questionnaire

    Time frame: 6 months maximum

    A multidimensional questionnaire has been built specifically for the study. An EVA scale is used to assess whether the patient has experienced discomfort, pain or discomfort (0-10). The higher the score, the more severe the discomfort.

    Ease of installation of the device and intention to use it on a daily basis if this was possible are evaluated by questions with binary responses (yes or no).

    Free fields are used to complete these responses and to suggest improvements of the prototype.

    This score will be assessed at the end of Visit 2

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: TREM-AB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 2, 2024
Registry last updated
Apr 29, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.