An interventional study of TREM-AB in Essential Tremor, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
257 studies on the registry are indexed under Tremor; 59 are open to participants now.
This study's enrollment of 5 is below the median of 25 across 184 interventional studies indexed under Tremor.
Browse Tremor studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Criteria for premature discharge
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
Wearing medical device on site during 1 hour
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.
Time frame: 6 months maximum
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.
Time frame: 6 months maximum
Tolerance to wearing the device
Adverse reactions occurring during use of the device
Time frame: 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
Time frame: 6 months maximum
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon