Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TREM-AB | Device | Wearing medical device on site during 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tolerance to wearing the device |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Criteria for premature discharge
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stéphane THOBOIS, MS, PhD | Hopital neurologique Pierre Wertheimer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Pathologies du mouvement et neuromusculaire, Hopital neurologique Pierre Wertheimer | Bron | 69500 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Adverse reactions occurring during use of the device |
| 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 | 6 months maximum |