Nonlinear Absorber in Essential Tremor Treatment

NCT ID: NCT06397391

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2025-04-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

TREM-AB

Intervention Type: DEVICE

Wearing medical device on site during 1 hour

Interventions

TREM-AB

Wearing medical device on site during 1 hour

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane THOBOIS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital neurologique Pierre Wertheimer

Locations

Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer

Bron, , France

Countries

France

Other Identifiers

69HCL21_0984

Identifier Type: -

Identifier Source: org_study_id