Nonlinear Absorber in Essential Tremor Treatment (TREM-AB)

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.

Study Overview

• Status: Completed
• Conditions: Essential Tremor
• Intervention / Treatment: Device: TREM-AB

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical device; Patients will test medical device on site during 1 hour. EMG (electromyogram) and accelerometry will be performed before and after this hour. As same as clinical scale (Fahn-tolosa-Marin)	Device: TREM-AB; Wearing medical device on site during 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tremor improvement	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.	6 months maximum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tremor frequency	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.	6 months maximum
Tolerance to wearing the device	Adverse reactions occurring during use of the device	6 months maximum
Patient satisfaction with the device measured by a specific multidimensional questionnaire	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	6 months maximum

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Stéphane THOBOIS, MS, PhD, Hôpital Neurologique Pierre Wertheimer

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Essential tremor; Passive treatment; Nonlinear absorber
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Tremor; Essential Tremor
• Other Study ID Numbers: 69HCL21_0984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No