Essential TremorNCT05795218
directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor
An observational study of Essential Tremor, run by Aleva Neurotherapeutics SA at 5 sites in Germany.
Trial summary
This is a prospective, multi-center, single arm post-market clinical follow-up study. The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 5 sitesGermany
- Study dates
- 21 Jun 2021to 8 Aug 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty-one patients suffering from Essential Tremor, referred for DBS surgery, who chose directSTIM, will be enrolled in a minimum of 3 sites in Europe to collect primary safety and effectiveness variables baseline and 3 months post-surgery. The sample size has been determined for the primary effectiveness endpoint. Study subjects will be representative of the target population since they will be recruited among patients who discussed the need and agreed with their clinician upon the implant of a DBS System to treat their motor symptoms caused by Essential Tremor.
Who may be able to join
- Patient is 18 years of age or older.
- Patient with main tremor symptoms in upper limbs.
- Patient was referred for DBS surgery to treat Essential Tremor and chose the directSTIM DBS System
- Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor with medication, for the worst limb (i.e. most affected by disease)
- Patient accepts to abstain from caffeine for 8 hours and from alcohol for 12 hours before visit.
- Patient accepts to turn stimulation off for 1 hour prior to the 3-month follow-up visit.
- Patient is willing to provide a written informed consent.
- Patient is available for the study visit, and other study requirements.
Who cannot join
- Cognitive impairment, or any characteristic that would limit study candidate's ability to complete study assessments, such as:
- Active major psychiatric disorder (including clinically significant depression as rated by the clinician)
- Patient had dementia interfering with their ability to co-operate or comply with study requirements or comprehend the informed consent (mini-mental exam score <24 or otherwise not capable of discernment)
- Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker)
- Previous brain ablation/surgical procedure
- Neurological injury, evidence of supraspinal central nervous system disease
Show all 11Show fewer
- History of seizures
- Diathermy
- Abuse of drugs or alcohol.
- Patient had botulinum toxin injection less than 6 months prior to enrollment
- Patient is participating in another clinical study that would confound data analysis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitätsklinikum Hamburg
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Münster
Münster, 48149
About this study
Official title: A Prospective, Multi-center, Single Arm, Observational, Post-market Clinical Follow-up Study on the Use of the directSTIM™ Deep Brain Stimulation System to Treat Essential Tremor
This is a prospective, multi-center, single arm post-market clinical follow-up study.
The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care.
Read more
This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system.
Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria.
Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors.
After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care.
Study will be conducted at minimum 3 centers in Europe.
Read the detailed description
This study investigates the benefits and safety of the use of the directSTIM Deep Brain Stimulation (DBS) system within its intended use, to deliver DBS therapy to patients suffering from Essential Tremor (ET) whose motor symptoms are no longer optimally controlled through pharmaceutical treatment.
The objective of this study is to show that directSTIM is not inferior to competitor DBS Systems at alleviating postural or kinetic symptoms of Essential Tremor through the delivery of Deep Brain Stimulation therapy.
Data to be analyzed will be collected from ET patients referred for DBS surgery, who chose to get the directSTIM DBS System implanted after discussing its risks and benefits with their clinician.
All procedures involving the patient and the device follow the standard of care in place at the site for DBS.
- Conditions
- Essential Tremor
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called DBS
implant and DBS therapy with the directSTIM™ DBS system
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb
The motor scale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) measures the maximum tremor severity in various body regions in different positions (rest, postural, kinetic).
Each body area is evaluated in Part A of the FTM ETRS, which is composed of 10 questions.
The FTM ETRS utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The target limb (arm) will be identified at baseline for each patient as the limb most severely affected by tremors (highest score in postural or kinetic assessment in part A).
The primary efficacy outcome is the mean percentage difference, 3 months post-implant, between the with and without stimulation states, as measured on the target limb identified at baseline, by the individual performance subscale score (i.e. postural or kinetic) on the FTM ETRS.
Measured: 3 months
Secondary outcomes (2)
Proportions of Adverse Events and Device Deficiencies observed
Proportions of the following events from DBS implant through study completion:
- Adverse Events:
- Surgery-related
- Device-related
- Therapy-related
- Device deficiencies
Measured: 3 months
Change in total motor score on the Fahn Tolosa Marin Essential Tremor Rating Scale
The motor scale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) measures the maximum tremor severity in various body regions in different positions (rest, postural, kinetic).
FTM ETRS is divided into 3 parts (A, B and C). The total motor score is calculated by summation of the individual scores to questions 1-15 of parts A and B.
Maximum score of Part A is 88 points while that of Part B is of 36 points.
The secondary efficacy OBJECTIVE is the mean difference between the with and without stimulation states, 3 months post-implant, as measured by the total motor score on the FTM ETRS.
A high total motor score (i.e. close to 124) indicates overall poor motor performance - i.e. severe tremor.
High difference value between total motor score measured with and without stimulation indicates a strong improvement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start21 Jun 2021
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Why it stopped: Insolvency of the business
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleva Neurotherapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Michalis, Study director, Aleva Neurotherapeutics SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795218
- Sponsor's protocol ID
- CLI-12082
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2022
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single Arm, Observational, Post-market Clinical Follow-up Study on the Use of the directSTIM™ Deep Brain Stimulation System to Treat Essential Tremor
- ClinicalTrials.gov ID
- NCT05795218
- Acronym / sponsor ID
- CLI-12082
- Conditions
- Essential Tremor
- Keywords
- Deep Brain Stimulation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insolvency of the business
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aleva Neurotherapeutics SAIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 3 Apr 2023 (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.
This is a prospective, multi-center, single arm post-market clinical follow-up study.
The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care.
This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system.
Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria.
Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors.
After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care.
Study will be conducted at minimum 3 centers in Europe.
Detailed description
This study investigates the benefits and safety of the use of the directSTIM Deep Brain Stimulation (DBS) system within its intended use, to deliver DBS therapy to patients suffering from Essential Tremor (ET) whose motor symptoms are no longer optimally controlled through pharmaceutical treatment.
The objective of this study is to show that directSTIM is not inferior to competitor DBS Systems at alleviating postural or kinetic symptoms of Essential Tremor through the delivery of Deep Brain Stimulation therapy.
Data to be analyzed will be collected from ET patients referred for DBS surgery, who chose to get the directSTIM DBS System implanted after discussing its risks and benefits with their clinician.
All procedures involving the patient and the device follow the standard of care in place at the site for DBS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-one patients suffering from Essential Tremor, referred for DBS surgery, who chose directSTIM, will be enrolled in a minimum of 3 sites in Europe to collect primary safety and effectiveness variables baseline and 3 months post-surgery. The sample size has been determined for the primary effectiveness endpoint. Study subjects will be representative of the target population since they will be recruited among patients who discussed the need and agreed with their clinician upon the implant of a DBS System to treat their motor symptoms caused by Essential Tremor.
Key inclusion criteria (8 listed)
- Patient is 18 years of age or older.
- Patient with main tremor symptoms in upper limbs.
- Patient was referred for DBS surgery to treat Essential Tremor and chose the directSTIM DBS System
- Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor with medication, for the worst limb (i.e. most affected by disease)
- Patient accepts to abstain from caffeine for 8 hours and from alcohol for 12 hours before visit.
Key exclusion criteria (11 listed)
- Cognitive impairment, or any characteristic that would limit study candidate's ability to complete study assessments, such as:
- Patient had botulinum toxin injection less than 6 months prior to enrollment
- Patient is participating in another clinical study that would confound data analysis.
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 |
|---|---|---|
| Deep Brain StimulationAlso: DBSimplant and DBS therapy with the directSTIM™ DBS system | Device | – |
Primary outcome
Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb
Time frame: 3 months
The motor scale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) measures the maximum tremor severity in various body regions in different positions (rest, postural, kinetic). Each body area is evaluated in Part A of the FTM ETRS, which is composed of 10 questions. The FTM ETRS utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The target limb (arm) will be identified at baseline for each patient as the limb most severely affected by tremors (highest score in postural or kinetic assessment in part A). The primary efficacy outcome is the mean percentage difference, 3 months post-implant, between the with and without stimulation states, as measured on the target limb identified at baseline, by the individual performance subscale score (i.e. postural or kinetic) on the FTM ETRS.
2 secondary outcomes
Proportions of Adverse Events and Device Deficiencies observed
Time frame: 3 months
Change in total motor score on the Fahn Tolosa Marin Essential Tremor Rating Scale
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Insolvency of the business). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Alexandre Michalis study director
Aleva Neurotherapeutics SA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, run by Aleva Neurotherapeutics SA at 5 sites in Germany.
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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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 was stopped early (reason given: Insolvency of the business). Results are not available in the source record.
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?
Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb (time frame: 3 months). 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 9 Aug 2024.