Essential TremorNCT04581941
Deep Brain Stimulation Effects in Essential Tremor
An observational study of Essential Tremor, run by University of Florida at 1 site in United States.
Trial summary
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory essential tremor. However, DBS programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Essential Tremor
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2020to 30 May 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with essential tremor, who have been cleared for DBS surgery.
Who may be able to join
- Patient gives an informed consent.
- Patient is over 21 years of age.
- Having a diagnosis of a essential tremor confirmed by a trained movement disorders neurologist;
- Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;
Who cannot join
- Having alternative diagnoses to essential tremor;
- Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease or dystonia);
- Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
- History of prior resective brain surgery (e.g. tumor resection);
- Not being a DBS candidate;
- Receiving unilateral implants
- Having a higher surgical risk that precludes patient from having standard intraoperative mapping.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation Effects in Essential Tremor: Time Course of Electrophysiological Changes in Treatment
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory essential tremor. However, DBS programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. The investigators aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. The investigators will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming.
Read the detailed description
The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. The is now the ability to stream brain signals from a newly FDA approved device, the Medtronic Percept. The investigators will study the longitudinal effects of DBS on the brain signals that are found to correlate with tremor severity as measured with wireless wearable sensors.
- Conditions
- Essential Tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with essential tremor | Patients with essential tremor who have clinically been deemed candidates for DBS (Deep Brain Stimulation) surgery. Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses. This intervention is not part of the study. The investigators are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fahn- Tolosa- Marin Tremor Rating Scale
A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start5 Dec 2020
- Primary completion30 May 2024
- Study completion30 May 2024
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581941
- Sponsor's protocol ID
- IRB202002623
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2020
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Effects in Essential Tremor: Time Course of Electrophysiological Changes in Treatment
- ClinicalTrials.gov ID
- NCT04581941
- Acronym / sponsor ID
- IRB202002623
- Conditions
- Essential Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 9 Oct 2020 (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.
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory essential tremor. However, DBS programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. The investigators aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. The investigators will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming.
Detailed description
The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. The is now the ability to stream brain signals from a newly FDA approved device, the Medtronic Percept. The investigators will study the longitudinal effects of DBS on the brain signals that are found to correlate with tremor severity as measured with wireless wearable sensors.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with essential tremor | – | –Patients with essential tremor who have clinically been deemed candidates for DBS (Deep Brain Stimulation) surgery. Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses. This intervention is not part of the study. The investigators are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with essential tremor, who have been cleared for DBS surgery.
Key inclusion criteria (4 listed)
- Patient gives an informed consent.
- Patient is over 21 years of age.
- Having a diagnosis of a essential tremor confirmed by a trained movement disorders neurologist;
- Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;
Key exclusion criteria (7 listed)
- Having alternative diagnoses to essential tremor;
- Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease or dystonia);
- Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
- History of prior resective brain surgery (e.g. tumor resection);
- Not being a DBS candidate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fahn- Tolosa- Marin Tremor Rating Scale
Time frame: 6 months
A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 University of Florida at 1 site 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 4 inclusion and 7 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fahn- Tolosa- Marin Tremor Rating Scale (time frame: 6 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 Oct 2024.