Reduction of tremor in essential tremor patients by use of a new anti-tremor device
| ISRCTN | ISRCTN17323638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17323638 |
| Secondary identifying numbers | NL79108.000.21 |
- Submission date
- 03/05/2023
- Registration date
- 30/05/2023
- Last edited
- 15/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Essential tremor is the most common neurological movement disorder. Tremor in the arms affects fine motor control and can lead to impairment in activities of daily living, such as writing, drinking or writing. Current treatments to suppress essential tremors, such as medication (e.g., propranolol, primidon) and deep brain stimulation, often do not have the desired effectiveness and/or have side effects and risks. In this study, a new anti-tremor orthosis (device) that aims to reduce tremors by adding artificial (passive) damping to the joints in the forearm, is evaluated for its effectiveness, patient satisfaction and adverse events.
Who can participate?
Patients aged over 18 years with essential tremor
What does the study involve?
Participants perform seven standardized tasks in three conditions: baseline (wearing no devices), wearing a sham device, and wearing the new anti-tremor orthosis. They are randomly assigned to either the sham device first or the orthosis first and do not know which device was the sham or the orthosis, but the investigator will know.
What are the possible benefit and risks of participating?
The benefit of participating is contributing to research that could potentially lead to a new treatment option for essential tremor patients. Risks are deemed minor: the interventional devices are non-invasive, do not use nerve- or muscle stimulation, and participants wear the devices for a short period in a controlled clinical setting. Expected side effects are redness of the skin or hand discomfort. Apart from travel cost reimbursement, participants receive no reimbursement.
Where is the study run from?
The Reinier de Graaff Hospital (The Netherlands)
When is the study starting and how long is it expected to run for? -
August 2021 to October 2022.
Who is funding the study?
The Reinier de Graaff Hospital (The Netherlands)
Who is the main contact?
Daan Kamphuis, kamphuis@rdgg.nl
Contact information
Principal Investigator
Reinier de Graafweg 5
Delft
2625AD
Netherlands
| Phone | +31 (0)152603751 |
|---|---|
| kamphuis@rdgg.nl |
Study information
| Study design | Single-center single-blind randomized crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | The effect of a novel anti-tremor orthosis on reduction of forearm tremor in essential tremor patients - a single-blind randomized crossover study |
| Study hypothesis | A novel anti-tremor orthosis reduces tremor severity and tremor amplitude in essential tremor patients with a dominant forearm tremor, in comparison with baseline (no orthosis) or a sham device. |
| Ethics approval(s) | Approved 21/12/2021, amended 01/08/2022, the Dutch medical-ethical committee of Leiden-Delft-Den Haag (METC LDD, Kamer P5-22, Route 953, Postzone P5-P, Postbus 9600, 2300 RC Leiden, the Netherlands; +31 (0)71 526 5106; n.feller@lumc.nl), ref: NL79108.000.21 |
| Condition | Reduction of tremor in patients with essential tremor with a dominant forearm tremor. |
| Intervention | An algorithm within the CRF software, which includes the API that is used to acquire the motion data, will randomly determine the order of the sham device and intervention. Only the investigator can see which device is selected, thereby blinding the patient. The investigator will obtain the selected device using colour-coded tabs and attach it to the patient’s arm/hand. Both devices will have a comparable look and weight. The study compared participants in three conditions: baseline (no orthosis), wearing a sham device; and wearing the novel anti-tremor orthosis. The sham device, albeit identical in weight and appearance to the orthosis, contained no damping elements designed for tremor suppression and did not restrain movement of the forearm. Each participant started with the baseline condition and was then randomly assigned to either sham first or orthosis first, resulting in two groups of equal subjects. For each condition, participants performed seven tasks (static posture, wing-beat posture, finger-to-nose, spiral drawing, pouring, drinking, and eating) from the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) scale in a clinical setting. All tasks were video-recorded, allowing assessment of the TETRAS scale after the interventions. Accelerometry data were gathered from two IMUs placed on the wrist and hand of the participants. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | STIL anti-tremor orthosis |
| Primary outcome measure | Measured at a single timepoint: 1. Tremor severity is measured using the TETRAS scale (score: 0-28), assessed by neurologists with specialization in movement disorders, for each intervention 2. Tremor power is measured using accelerometry data, recorded by two inertial movement units (IMU) located at the wrist and hand of the subjects, during each intervention |
| Secondary outcome measures | Measured at a single timepoint: 1. Patient satisfaction with the sham device and the orthosis, measured using the Dutch Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST), ranging on a scale from 1 (not at all satisfied) to 5 (very satisfied) 2. Adverse events, both reported by subjects as well as observed by the investigator |
| Overall study start date | 01/08/2021 |
| Overall study end date | 19/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 24 |
| Participant inclusion criteria | 1. Diagnosed with essential tremor 2. Substantial perceived disability due to tremor in the arm, assessed from Bain and Findley ADL score (>30) 3. Tremor severity score >13 on subset (ADL tasks and upper-limb tasks) of the TETRAS scale 4. Dominant wrist flexion-extension and forearm pronation-supination tremor 5. Above 18 years old |
| Participant exclusion criteria | 1. Dominant shoulder internal-external rotation tremor 2. Dominant elbow flexion-extension tremor 3. Excessive alcohol consumption, as defined in the Dutch GGZ guidelines on alcohol use 4. Previous or planned deep brain stimulation (DBS) at the time of study enrollment that interferes with testing 5. Previous or planned thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor at the time of study enrollment that interferes with testing 6. Change in medications related to tremor disorder in the 30 days prior to study enrollment 7. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin on the forearm or hand that would interfere with wearing the orthosis during the clinical investigation 8. Peripheral neuropathy affecting the tested upper extremity (e.g. carpal tunnel syndrome) 9. The suspicion or confirmation that head tremor may cause impairment in performing ADL tasks 10. Diagnosed Parkinson’s disease, this includes the presence of parkinsonian features 11. Diagnosed functional tremor 12. Diagnosed physiologic tremor 13. Diagnosed cerebellar tremor 14. Diagnosed multiple sclerosis (MS) 15. Diagnosed ataxia 16. Patients with an amputation of one or both upper extremities. 17. Subjects with restricted movement or restricted muscle function in the arm and or hand (e.g. contractures) |
| Recruitment start date | 10/03/2022 |
| Recruitment end date | 19/10/2022 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Delft
2625 AD
Netherlands
Sponsor information
Hospital/treatment centre
Reinier de Graafweg 5
Delft
2625AD
Netherlands
| Phone | +31 (0)15 260 3060 |
|---|---|
| Wetenschapsbureau@rdgg.nl | |
| Website | https://reinierdegraaf.nl/ |
"ROR" |
https://ror.org/00wkhef66 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 10/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.4 | 11/05/2023 | No | No |
Additional files
Editorial Notes
15/11/2023: The intention to publish date was changed from 10/10/2023 to 10/10/2024.
11/05/2023: Study's existence confirmed by the Dutch medical-ethical committee of Leiden-Delft-Den Haag (METC LDD).
