Nonlinear Absorber in Essential Tremor Treatment

Essential Tremor Clinical Trial

— TREM-AB  

Official title:

Nonlinear Absorber in Essential Tremor Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397391
• Other study ID #: 69HCL21_0984
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Stéphane THOBOIS, MS, PhD
• Phone: 04 72 11 80 22
• Email: stephane.thobois[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• TREM-AB
Wearing medical device on site during 1 hour

Locations

Country	Name	City	State
France	Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Tolerance to wearing the device	Adverse reactions occurring during use of the device	6 months maximum
Secondary	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