Essential TremorTREM-ABNCT06397391
Nonlinear Absorber in Essential Tremor Treatment
A study testing TREM-AB in people with Essential Tremor, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- TREM-AB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2024to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
France1 site
Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer
Bron, 69500
About this study
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
- Being tested
- TREM-AB
- Keywords
- Essential tremor, Passive treatment, Nonlinear absorber
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREM-ABDevice
Wearing medical device on site during 1 hour
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: TREM-AB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months maximum
Secondary outcomes (3)
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.
Measured: 6 months maximum
Tolerance to wearing the device
Adverse reactions occurring during use of the device
Measured: 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
Measured: 6 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start30 Aug 2024
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane THOBOIS, MS, PhD, Principal investigator, Hopital neurologique Pierre Wertheimer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397391
- Sponsor's protocol ID
- 69HCL21_0984
- Acronym
- TREM-AB
- Status last verified
- Apr 2025
- First submitted
- 23 May 2022
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonlinear Absorber in Essential Tremor Treatment
- ClinicalTrials.gov ID
- NCT06397391
- Acronym / sponsor ID
- TREM-AB / 69HCL21_0984
- Conditions
- Essential Tremor
- Keywords
- Essential tremor, Passive treatment, Nonlinear absorber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical device | Experimental | Device: TREM-ABPatients 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) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREM-ABWearing medical device on site during 1 hour | Device | Medical device |
Primary outcome
Tremor improvement
Time frame: 6 months maximum
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.
3 secondary outcomes
Tremor frequency
Time frame: 6 months maximum
Tolerance to wearing the device
Time frame: 6 months maximum
Patient satisfaction with the device measured by a specific multidimensional questionnaire
Time frame: 6 months maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Essential Tremor
Active, not recruitingObservational study
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Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
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Phenotype/Genotype Correlations in Movement Disorders
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Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane THOBOIS, MS, PhD principal investigator
Hopital neurologique Pierre Wertheimer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREM-AB in people with Essential Tremor, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor improvement (time frame: 6 months maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.