Essential TremorNCT04828798
Directional Versus Nondirectional DBS for ET
A study testing Deep brain stimulation of the VIM Thalamic nuclei in people with Essential Tremor, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Deep brain stimulation of the VIM Thalamic nuclei
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Oct 2029
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration
Who cannot join
- Patients who have decided not to receive DBS for control of their medication-refractory essential tremor.
- Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia).
- Prior history of deep brain stimulation.
- Prior history of thalamotomy.
- A history or signs of dystonia, ataxia or parkinsonism.
- Task specific tremor.
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- Orthostatic tremor.
- Patients with cardiac pacemakers, defibrillators, or neurostimulators.
- Patients who require MRI, ECT, rTMS, or diathermy.
- Subjects with other type of neurological disease or injury.
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
Oregon Health & Science University
Portland, Oregon, 97239
Zoe Fanning, 503-494-7772, fanningz@ohsu.edu
About this study
Official title: Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance
This will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS.
Read the detailed description
Specific Aims:
- To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor. Hypothesis: directional DBS will result in a wider TW than nondirectional DBS.
- To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
- To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
- To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.
- Conditions
- Essential Tremor
- Being tested
- Deep brain stimulation of the VIM Thalamic nuclei
- 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 stimulation of the VIM Thalamic nucleiDevice
Deep brain stimulation of the thalamus, in a directional and nondirectional manner
| Study group | Role | What they receive |
|---|---|---|
| Directional deep brain stimulation | Active comparator | Deep brain stimulation delivered in a directional manner within an axial plane Receives: Device: Deep brain stimulation of the VIM Thalamic nuclei |
| Nondirectional deep brain stimulation | Active comparator | Deep brain stimulation delivered in a nondirectional manner within an axial plane Receives: Device: Deep brain stimulation of the VIM Thalamic nuclei |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic window
Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps
Measured: 3 months
Secondary outcomes (4)
Improvement of tremor
Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome.
Measured: 3 months
Compare the effects of directional versus nondirectional DBS on self perception of speech
Self Perception of speech: Subjects will rate their "ability to speak" on a VAS (from 0 [normal] to 100 mm [worst]) in each condition.
Measured: 3 months
Compare the effects of directional versus nondirectional DBS on balance and gait
The Activities-specific Balance Confidence (ABC) scale is a 16-item self-report measure in which participants rate their balance confidence on a 0-100 scale (0 = 0 no confidence, 100 = 100 complete confidence).
Measured: 3 months
Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech
Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS).
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 posted2 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2029 (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.
- More trials run by Oregon Health and Science UniversityThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brodsky, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828798
- Sponsor's protocol ID
- STUDY00020724
- Status last verified
- Oct 2025
- First submitted
- 8 Feb 2021
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance
- ClinicalTrials.gov ID
- NCT04828798
- Acronym / sponsor ID
- STUDY00020724
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 2 Apr 2021 (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 will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS.
Detailed description
Specific Aims:
- To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor. Hypothesis: directional DBS will result in a wider TW than nondirectional DBS.
- To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
- To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
- To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded crossover design
| Arm | Type | Receives |
|---|---|---|
| Directional deep brain stimulation | Active comparator | Device: Deep brain stimulation of the VIM Thalamic nucleiDeep brain stimulation delivered in a directional manner within an axial plane |
| Nondirectional deep brain stimulation | Active comparator | Device: Deep brain stimulation of the VIM Thalamic nucleiDeep brain stimulation delivered in a nondirectional manner within an axial plane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration
Key exclusion criteria (10 listed)
- Patients who have decided not to receive DBS for control of their medication-refractory essential tremor.
- Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia).
- Prior history of deep brain stimulation.
- Prior history of thalamotomy.
- A history or signs of dystonia, ataxia or parkinsonism.
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 stimulation of the VIM Thalamic nucleiDeep brain stimulation of the thalamus, in a directional and nondirectional manner | Device | Directional deep brain stimulation, Nondirectional deep brain stimulation |
Primary outcome
Therapeutic window
Time frame: 3 months
Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps
4 secondary outcomes
Improvement of tremor
Time frame: 3 months
Compare the effects of directional versus nondirectional DBS on self perception of speech
Time frame: 3 months
Compare the effects of directional versus nondirectional DBS on balance and gait
Time frame: 3 months
Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech
Time frame: 3 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 30 Oct 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation of the VIM Thalamic nuclei in people with Essential Tremor, run by Oregon Health and Science University 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 1 inclusion and 10 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 30 Oct 2025. 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?
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 Zoe Fanning (503-494-7772, fanningz@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic window (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 30 Oct 2025.