Directional Versus Nondirectional DBS for ET
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ClinicalTrials.gov Identifier: NCT04828798 |
Recruitment Status :
Recruiting
First Posted : April 2, 2021
Last Update Posted : April 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Tremor | Device: Deep brain stimulation of the VIM Thalamic nuclei | Not Applicable |
Specific Aims:
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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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Double-blinded crossover design |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance |
Estimated Study Start Date : | April 1, 2021 |
Estimated Primary Completion Date : | August 8, 2023 |
Estimated Study Completion Date : | February 8, 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Directional deep brain stimulation
Deep brain stimulation delivered in a directional manner within an axial plane
|
Device: Deep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner |
Active Comparator: Nondirectional deep brain stimulation
Deep brain stimulation delivered in a nondirectional manner within an axial plane
|
Device: Deep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner |
- 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
- Improvement of tremor [ Time Frame: 3 months ]Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome.
- Compare the effects of directional versus nondirectional DBS on self perception of speech [ Time Frame: 3 months ]Self Perception of speech: Subjects will rate their "ability to speak" on a VAS (from 0 [normal] to 100 mm [worst]) in each condition.
- Compare the effects of directional versus nondirectional DBS on balance and gait [ Time Frame: 3 months ]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).
- Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech [ Time Frame: 3 months ]Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS).

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828798
Contact: Zoe Fanning | 503-494-7772 | fanningz@ohsu.edu |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Zoe Fanning 503-494-7772 fanningz@ohsu.edu |
Responsible Party: | Matthew Brodsky, Associate Professor of Neurology, Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT04828798 |
Other Study ID Numbers: |
99920724 |
First Posted: | April 2, 2021 Key Record Dates |
Last Update Posted: | April 2, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Tremor Essential Tremor Dyskinesias Neurologic Manifestations |
Nervous System Diseases Movement Disorders Central Nervous System Diseases |