Essential TremorNCT03051178
Wearable Sensor for Responsive DBS for ET
A study testing Responsive deep brain stimulation in people with Essential Tremor, run by University of Florida at 2 sites in United States.
Trial summary
The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography (EMG). This therapy is called Responsive Deep Brain Stimulation (R-DBS). Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Responsive deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2018to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide informed consent
- Patient is over 21 years of age
- Patient has had a significant disabling, medication-refractory upper extremity tremor with no evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation of Activa SC, PC, or RC device.
- Patient receives Vim electrode and Activa SC, PC or RC device implants, and recovers fully after surgery.
- Patient is available for study participation after their clinical programming appointments for six months.
Who cannot join
- Medication related movement disorders.
- Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.
- Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, continuous neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians.
- Patient is undergoing a lead revision surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health
Gainesville, Florida, 32610
Biomedical Sciences Building
Gainesville, Florida, 32611
About this study
Official title: Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor
The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography (EMG). This therapy is called Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer, and apply stimulation when the computer detects patterns associated with tremor. This detection will suppress pathological activity and improve or alleviate the tremor.
Currently, DBS is approved for the treatment of ET; however, stimulation is delivered continuously even when tremor or other symptoms are absent. Continuous DBS can lead to unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS will turn on only if activity associated with ET from the external sensors is detected.
Read the detailed description
The overall purpose of this application is to capture pathological activity related to essential tremor using external wearable sensors to responsively initiate or terminate DBS. To this end, the researchers propose to use the Nexus-D system, which requires a firm ware update to an Activa Implantable Neurostimulator (INS), and it will in a smart way turn DBS on/off in patients. The study team will recruit subjects with Activa SC or PC neurostimulator implants during 6 post-operative programming visits. The research group is already familiar with and is in possession of the Nexus-D system, and the investigators have successfully performed responsive DBS in two patients with Tourette syndrome (TS) and in four patients with Parkinson's disease in acute settings. The lab is also equipped with wireless wearable sensor and amplifier systems, such as a 16-unit wireless EMG+ acceleration+inertia Trigno Wireless Bio Acquisition System (Delsys Inc, Natick, MA). The study team aims to combine these signal modalities to capture pathological symptoms and generate commands to initiate or terminate DBS (also record adverse side effects, if any). The project goal is to characterize the clinical efficacy, side effect profile, and battery life of closed-loop DBS in acute settings using wearable sensors in essential tremor patients.
- Conditions
- Essential Tremor
- Being tested
- Responsive 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.
Responsive deep brain stimulationDevice
Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Essential Tremor | Experimental | This cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors. Receives: Device: Responsive deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Rating Scale for Tremor (CRST)
Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation. Clinical Tremor Rating Scale (TRS), rated by a blinded neurologist, during responsive brain stimulation will be compared to scores during continuous deep brain stimulation and no stimulation. The minimum and maximum score range for this scale is 0-80, with higher score indicating worse outcome.
Measured: 30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start18 Sep 2018
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, De Luca Foundation, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Aysegul Gunduz, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051178
- Sponsor's protocol ID
- IRB201602458 -A
- Other IDs
- OCR17477, 1F31NS115363-01A1, UH3NS095553
- Status last verified
- Oct 2022
- First submitted
- 9 Feb 2017
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor
- ClinicalTrials.gov ID
- NCT03051178
- Acronym / sponsor ID
- IRB201602458 -A
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Medtronic, De Luca Foundation, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 28 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography (EMG). This therapy is called Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer, and apply stimulation when the computer detects patterns associated with tremor. This detection will suppress pathological activity and improve or alleviate the tremor.
Currently, DBS is approved for the treatment of ET; however, stimulation is delivered continuously even when tremor or other symptoms are absent. Continuous DBS can lead to unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS will turn on only if activity associated with ET from the external sensors is detected.
Detailed description
The overall purpose of this application is to capture pathological activity related to essential tremor using external wearable sensors to responsively initiate or terminate DBS. To this end, the researchers propose to use the Nexus-D system, which requires a firm ware update to an Activa Implantable Neurostimulator (INS), and it will in a smart way turn DBS on/off in patients. The study team will recruit subjects with Activa SC or PC neurostimulator implants during 6 post-operative programming visits. The research group is already familiar with and is in possession of the Nexus-D system, and the investigators have successfully performed responsive DBS in two patients with Tourette syndrome (TS) and in four patients with Parkinson's disease in acute settings. The lab is also equipped with wireless wearable sensor and amplifier systems, such as a 16-unit wireless EMG+ acceleration+inertia Trigno Wireless Bio Acquisition System (Delsys Inc, Natick, MA). The study team aims to combine these signal modalities to capture pathological symptoms and generate commands to initiate or terminate DBS (also record adverse side effects, if any). The project goal is to characterize the clinical efficacy, side effect profile, and battery life of closed-loop DBS in acute settings using wearable sensors in essential tremor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Essential Tremor | Experimental | Device: Responsive deep brain stimulationThis cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide informed consent
- Patient is over 21 years of age
- Patient has had a significant disabling, medication-refractory upper extremity tremor with no evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation of Activa SC, PC, or RC device.
- Patient receives Vim electrode and Activa SC, PC or RC device implants, and recovers fully after surgery.
- Patient is available for study participation after their clinical programming appointments for six months.
Key exclusion criteria (4 listed)
- Medication related movement disorders.
- Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.
- Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, continuous neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians.
- Patient is undergoing a lead revision surgery.
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 |
|---|---|---|
| Responsive deep brain stimulationResponsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors. | Device | Subjects with Essential Tremor |
Primary outcome
Clinical Rating Scale for Tremor (CRST)
Time frame: 30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized.
Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation. Clinical Tremor Rating Scale (TRS), rated by a blinded neurologist, during responsive brain stimulation will be compared to scores during continuous deep brain stimulation and no stimulation. The minimum and maximum score range for this scale is 0-80, with higher score indicating worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Aysegul Gunduz, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responsive deep brain stimulation in people with Essential Tremor, run by University of Florida at 2 sites in United States.
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 5 inclusion and 4 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Rating Scale for Tremor (CRST) (time frame: 30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized.). 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 19 Apr 2024.