Nonlinear Absorber in Essential Tremor Treatment (TREM-AB)

Civil Hospices of Lyon

Status: Completed

Conditions: Essential Tremor

Treatments: Device: TREM-AB

Study type: Interventional

Funder types: Other

Identifiers

NCT06397391

69HCL21_0984

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Medical device

Experimental group

Description:

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)

Treatment:

Device: TREM-AB