Nonlinear Absorber in Essential Tremor Treatment

NCT06397391 | Completed

• 1 other identifier: 69HCL21_0984
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Tremor

Keywords

Essential tremor; Passive treatment; Nonlinear absorber

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tremor frequency

  6 months maximum

• Tolerance to wearing the device

  6 months maximum

• Patient satisfaction with the device measured by a specific multidimensional questionnaire

  6 months maximum

Study Arms (1)

Medical device

EXPERIMENTAL

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

Interventions

TREM-AB DEVICE

Wearing medical device on site during 1 hour

Medical device

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe comorbidity
• ET affecting only the leader
• Wounds on the forearm
• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer

Bron, 69500, France

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stéphane THOBOIS, MS, PhD

  Hopital neurologique Pierre Wertheimer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 2, 2024
• Study Start: August 30, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)