Essential TremorPhase 1NCT05897775
Coordinated Reset Deep Brain Stimulation for Essential Tremor
A Phase 1 study testing Deep brain stimulation in people with Essential Tremor and Upper Extremity Essential Tremor, run by University of Minnesota at 1 site in United States.
Trial summary
Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Essential Tremor, Upper Extremity Essential Tremor
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of essential tremor (ET)
- Age of 21 or over
- Will be or has been implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
- 7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging of DBS targets at 7T MRI". Participants who do not agree to get the 7T MRI under IRB #1210M22183 can still participate in this protocol. Alternatively, their clinical MRI scans will be used.
- Planned or completed post-operative CT scan
Who cannot join
- History of musculoskeletal disorders that affect movement of the limbs or gait
- Pregnant women
- Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
- Other significant medical disorder (e.g., depression, dementia, or cognitive impairment) that could impede study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Selam Woldegerima, 763-347-1287, wolde183@umn.edu
Jing Wang, PhD, (612) 626-6071, wang3444@umn.edu
About this study
Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation. This study will evaluate the feasibility, safety and short-term efficacy of thalamic CR-DBS in upper extremity ET. The goal of this study is to evaluate the safety and short-term efficacy of thalamic CR- DBS in ET, including the acute (during CR-DBS) and carryover (following DBS cessation) effects, and compare these to those induced by clinically optimized T-DBS. To achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (UE) ET. The first aim is to identify the spatial location and peak frequency of tremor related oscillatory activities in VIM (Phase I). The second aim is to compare the acute effects of thalamic CR-DBS to clinically optimized T-DBS (Phase II).
- Conditions
- Essential Tremor, Upper Extremity Essential Tremor
- Being tested
- 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
Thalamic coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude, high frequency stimulation.
Each participant will receive both the new intervention and the standard of care intervention, each for a week.
| Study group | Role | What they receive |
|---|---|---|
| Coordinated Reset DBS Setting (CR-DBS) | Experimental | Coordinated Reset DBS settings Receives: Device: Deep brain stimulation |
| Clinically Optimized DBS Setting (T-DBS) | Other | Traditional DBS settings Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
TETRAS is a rating scale introduced by the Tremor Research Group which has undergone extensive performance evaluations7. The TETRAS Activities of Daily Living Subscale (TETRAS-ADL) rates tremor's impact on activities of daily living, using 12 test items with each item scored from 0-4 (increasing with severity). The TETRAS-ADL total score range is 0-48.
The TETRAS performance subscale (TETRAS-P) consists of 16 scored items designed to measure essential tremor of the head, face, voice, upper extremity, lower extremity and trunk, with each item scored from 0-4 (increasing with severity). Specific amplitude measurements are used to guide the ratings for each item. Tasks of spiral drawing, handwriting and object holding are included. The TETRAS-P total score range is 0-64.
The total TETRAS score, including both TETRAS-ADL and TETRAS-P, ranges from 0 to 112.
Measured: 4 months
Secondary outcomes (8)
Instrumented Tremor Measurement
Quantitative measurements of upper extremity tremor can add power to clinical treatment trials 10,11 . Inertial measurement units (IMU) are lightweight, wearable motion sensors that offer a reliable means for the objective measurement of tremor 12 . In this trial Delsys IMU's will provide a secondary measure of tremor amplitude using recordings from a built-in accelerometer and gyroscope. IMU's will be attached to the arm muscles and recordings will be made during the upper extremity postural and action tasks of the TETRAS-P assessment, without adding additional assessment time.
Measured: 4 months
Bain Tremor Disability Scale (BTDS)
The Bain Findlay Tremor Activities of Daily Living scale is a 25-item self-administered questionnaire assessing items related to eating, hygiene, writing and other daily tasks (item rating 1-4, total score 25-100, increasing with severity). The scale is reliable in test-retest measures, although the correlation of disability scores to tremor amplitude measurements is not established.
Measured: 4 months
Quality of Life in Essential Tremor (QUEST)
QUEST is a quality of life measure specifically designed for essential tremor . The scale is a self-administered questionnaire of 30 items clustering around five factors: Physical, Psychosocial, Communication, Hobbies/Leisure, and Work/Finance. QUEST has good reliability (intraclass correlation coefficient >=.89) and correlates best with overall quality of life measures rather than upper extremity tremor severity.
Measured: 4 months
Quantitative Archimedes Spirals
Visual ratings of Archimedes Spiral drawing provide one of the most sensitive measures of tremor. Recording the spiral drawing on a digitizing tablet increases the sensitivity of tremor detection and can replace or augment clinical tremor measures. In this trial, patients will draw spirals on a Windows Surface tablet to obtain a quantitative measure of upper extremity tremor severity. The drawn spirals will be analyzed in MATLAB to output a score which correlates to severity of tremor.
Measured: 4 months
Dot Approximation Task
Subject will hold a pen/stylus above a dot on a white sheet of paper for ~10 seconds and try to keep the tip of the pen/stylus as close as possible to the dot without touching it. A MBIENTLAB IMU sensor will be wrapped around the middle finger to assess tremor. Data from the sensor will be logged in the tablet and analyzed in MATLAB to output a score. This task is a testing item in the TETRAS-P7. While TETRAS is challenging to assess remotely, the Dot Approximation Task is easy to perform and provides a sensitive, quantitative measure of tremor. Both the Quantitative Archimedes Spirals and Dot Approximation Tasks will be used for at-home self-assessment of tremor.
Measured: 4 months
Brief Ataxia Rating Scale (BARS)
The BARS was developed as a short screening instrument to rate cerebellar function in five realms: Gait, Kinetic Function-Arm, Kinetic Function-Leg, Speech, and Eye Movements. The scale is reliable (intraclass correlation coefficient = .91), internally consistent and correlates highly with other more detailed scales. The scale can be administered in minutes making it ideal for repeated assessment of dysfunction in cerebellothalamic pathways.
Measured: 2 months
Quantitative Gait Analysis
Gait ataxia is another common side-effect of DBS for ET. Marker-less pose estimation will be used to obtain a quantitative measure of gait ataxia by tracking the joints while the subject walks in a heel-to-toe, or tandem, manner. This data will be analyzed using DeepLabCut in Matlab to compute parameters such as midline deviation, gait speed, and wrist sway. Increased midline deviation and/or missteps, and a decrease in tandem gait speed will indicate gait ataxia.
Measured: 2 months
Quantitative Speech Analysis
Stimulation-induced dysarthria is a common side effect of DBS for ET. In this trial, speech tasks will be recorded and analyzed to compute several parameters. During the speech recording, the subject will perform the oral diadochokinesis task by repeating the syllables /ka/, /pa/, or /ta/ ten times each recruiting a different structure of articulation. These recordings will be analyzed using PRAAT (http://www.praat.org/) and custom MATLAB scripts to compute the voice duration and voice onset time. Prolonged voicing and decreased VOT are indicators of stimulation-induced dysarthria.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start11 Sep 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- Each participant will receive both the new intervention which is a new stimulation pattern and the standard of care intervention, each for a week.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Wang, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897775
- Sponsor's protocol ID
- NEUR-2023-31652
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Reset Deep Brain Stimulation for Essential Tremor
- ClinicalTrials.gov ID
- NCT05897775
- Acronym / sponsor ID
- NEUR-2023-31652
- Conditions
- Essential Tremor, Upper Extremity Essential Tremor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jun 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.
Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation. This study will evaluate the feasibility, safety and short-term efficacy of thalamic CR-DBS in upper extremity ET. The goal of this study is to evaluate the safety and short-term efficacy of thalamic CR- DBS in ET, including the acute (during CR-DBS) and carryover (following DBS cessation) effects, and compare these to those induced by clinically optimized T-DBS. To achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (UE) ET. The first aim is to identify the spatial location and peak frequency of tremor related oscillatory activities in VIM (Phase I). The second aim is to compare the acute effects of thalamic CR-DBS to clinically optimized T-DBS (Phase II).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will receive both the new intervention which is a new stimulation pattern and the standard of care intervention, each for a week.
| Arm | Type | Receives |
|---|---|---|
| Coordinated Reset DBS Setting (CR-DBS) | Experimental | Device: Deep brain stimulationCoordinated Reset DBS settings |
| Clinically Optimized DBS Setting (T-DBS) | Other | Device: Deep brain stimulationTraditional DBS settings |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of essential tremor (ET)
- Age of 21 or over
- Will be or has been implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
- 7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging of DBS targets at 7T MRI". Participants who do not agree to get the 7T MRI under IRB #1210M22183 can still participate in this protocol. Alternatively, their clinical MRI scans will be used.
- Planned or completed post-operative CT scan
Key exclusion criteria (4 listed)
- History of musculoskeletal disorders that affect movement of the limbs or gait
- Pregnant women
- Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
- Other significant medical disorder (e.g., depression, dementia, or cognitive impairment) that could impede study participation
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 stimulationThalamic coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude, high frequency stimulation. Each participant will receive both the new intervention and the standard of care intervention, each for a week. | Device | Clinically Optimized DBS Setting (T-DBS), Coordinated Reset DBS Setting (CR-DBS) |
Primary outcome
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
Time frame: 4 months
TETRAS is a rating scale introduced by the Tremor Research Group which has undergone extensive performance evaluations7. The TETRAS Activities of Daily Living Subscale (TETRAS-ADL) rates tremor's impact on activities of daily living, using 12 test items with each item scored from 0-4 (increasing with severity). The TETRAS-ADL total score range is 0-48. The TETRAS performance subscale (TETRAS-P) consists of 16 scored items designed to measure essential tremor of the head, face, voice, upper extremity, lower extremity and trunk, with each item scored from 0-4 (increasing with severity). Specific amplitude measurements are used to guide the ratings for each item. Tasks of spiral drawing, handwriting and object holding are included. The TETRAS-P total score range is 0-64. The total TETRAS score, including both TETRAS-ADL and TETRAS-P, ranges from 0 to 112.
8 secondary outcomes
Instrumented Tremor Measurement
Time frame: 4 months
Bain Tremor Disability Scale (BTDS)
Time frame: 4 months
Quality of Life in Essential Tremor (QUEST)
Time frame: 4 months
Quantitative Archimedes Spirals
Time frame: 4 months
Dot Approximation Task
Time frame: 4 months
Brief Ataxia Rating Scale (BARS)
Time frame: 2 months
Quantitative Gait Analysis
Time frame: 2 months
Quantitative Speech Analysis
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
Jing Wang, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep brain stimulation in people with Essential Tremor and Upper Extremity Essential Tremor, run by University of Minnesota 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 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang, PhD ((612) 626-6071, wang3444@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor Research Group Essential Tremor Rating Scale (TETRAS) (time frame: 4 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 20 Oct 2026.