Essential TremorNCT04758624
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
A study testing Deep Brain Stimulation in people with Essential Tremor, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- 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
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2021to 31 Aug 2027
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
- distal appendicular tremor, with minimal proximal component
- tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
- tremor judged to be severely impacting their quality of life.
Who cannot join
- significant neurological disorder
- significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
- severe psychiatric illness with suicidal ideations
- previous surgery to destroy the target region of the brain
- surgical contraindications to DBS
- current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
Show all 10Show fewer
- family history of hereditary neurologic disorder, besides essential tremors ET
- floating metallic objects in the body
- pregnancy
- alcohol or substance abuse/dependence in the past 6 months.
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
North Shore University Hospital
Manhasset, New York, 11030
Albert Fenoy
Prashin Unadkat
About this study
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
- Conditions
- Essential Tremor
- Being tested
- Deep Brain Stimulation
- Keywords
- 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
Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation(DBS) | Experimental | Not described Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Measured: Baseline before DBS implant
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Measured: 24 months after start of DBS
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Measured: Baseline before DBS implant
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Measured: 24 months after start of DBS
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Measured: Baseline before DBS implant
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Measured: 24 months after start of DBS
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Measured: Baseline before DBS implant
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Measured: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Measured: Baseline before DBS implant
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Measured: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Measured: Baseline before DBS is turned off
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Measured: 72 hours after DBS is turned off
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Measured: Baseline before DBS implant
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Measured: 24 months after start of DBS
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Measured: Baseline before DBS is turned off
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Measured: 72 hours after DBS is turned off
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Measured: During DBS placement surgery before active DBS
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Measured: During DBS placement surgery during active DBS
Spectral power recorded during intraoperative electrocorticography (ECoG)
Measured: During DBS placement surgery before active DBS
Spectral power recorded during intraoperative electrocorticography (ECoG)
Measured: During DBS placement surgery during active DBS
Secondary outcomes (6)
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Measured: Baseline before DBS implant
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Measured: 24 months after start of DBS
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Measured: Baseline before DBS is turned off
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Measured: 72 hours after DBS is turned off
Tremor amplitude as assessed by accelerometric power
Measured: Baseline before DBS is turned off
Tremor amplitude as assessed by accelerometric power
Measured: 72 hours after DBS is turned off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start4 Dec 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Albert J Fenoy, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758624
- Sponsor's protocol ID
- HSC-MS-20-0739
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Conner CR, Forseth KJ, Lozano AM, Ritter R 3rd, Fenoy AJ. Thalamo-cortical evoked potentials during stimulation of the dentato-rubro-thalamic tract demonstrate synaptic filtering. Neurotherapeutics. 2024 Jan;21(1):e00295. doi: 10.1016/j.neurot.2023.10.005. Epub 2023 Dec 19.
PubMed 38237402
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
- ClinicalTrials.gov ID
- NCT04758624
- Acronym / sponsor ID
- HSC-MS-20-0739
- Conditions
- Essential Tremor
- Keywords
- deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 4 Dec 2021 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Feb 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.
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation(DBS) | Experimental | Device: Deep Brain Stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
- distal appendicular tremor, with minimal proximal component
- tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
- tremor judged to be severely impacting their quality of life.
Key exclusion criteria (10 listed)
- significant neurological disorder
- significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
- severe psychiatric illness with suicidal ideations
- previous surgery to destroy the target region of the brain
- surgical contraindications to DBS
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 StimulationMedtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on. | Device | Deep Brain Stimulation(DBS) |
Primary outcome
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: Baseline before DBS implant
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time frame: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: Baseline before DBS implant
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: 24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: Baseline before DBS is turned off
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Time frame: 72 hours after DBS is turned off
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: Baseline before DBS implant
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: 24 months after start of DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: Baseline before DBS is turned off
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: 72 hours after DBS is turned off
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: During DBS placement surgery before active DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Time frame: During DBS placement surgery during active DBS
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Spectral power recorded during intraoperative electrocorticography (ECoG)
Time frame: During DBS placement surgery before active DBS
Spectral power recorded during intraoperative electrocorticography (ECoG)
Time frame: During DBS placement surgery during active DBS
6 secondary outcomes
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: Baseline before DBS implant
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: 24 months after start of DBS
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: Baseline before DBS is turned off
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: 72 hours after DBS is turned off
Tremor amplitude as assessed by accelerometric power
Time frame: Baseline before DBS is turned off
Tremor amplitude as assessed by accelerometric power
Time frame: 72 hours after DBS is turned off
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 29 Sep 2026.
- Results publication: PubMed 38237402Conner CR, Forseth KJ, Lozano AM, Ritter R 3rd, Fenoy AJ. Thalamo-cortical evoked potentials during stimulation of the dentato-rubro-thalamic tract demonstrate synaptic filtering. Neurotherapeutics. 2024 Jan;21(1):e00295. doi: 10.1016/j.neurot.2023.10.005. Epub 2023 Dec 19.
- 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.
Albert J Fenoy, MD principal investigator
Northwell Health
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 in people with Essential Tremor, run by Northwell Health 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 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 29 Sep 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.
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 Mark Amandola (516 491 1054, mamandola@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI (time frame: Baseline before DBS implant). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04758624, which also lists 1 linked publication.
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 29 Sep 2026.