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RecruitingNCT04758624Updated Sep 29, 2026

Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract

An interventional study of Deep Brain Stimulation in Essential Tremor, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Northwell Health · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 11 months later.
Updated Sep 29, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Essential Tremor

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Keywords

  • deep brain stimulation
03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 72 is above the median of 25 across 189 interventional studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.

Browse Northwell Health studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 to multiple medication regimens and/or where the medications cause intolerable side effects
  • tremor judged to be severely impacting their quality of life.

Exclusion criteria

Exclusion Criteria:

  • 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 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)
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Deep Brain Stimulation(DBS)

    Device: Deep Brain Stimulation

Interventions

  • DeviceDeep Brain Stimulation

    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.

06

What researchers measure

Primary outcomes

  1. Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  2. Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  3. Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  4. Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  5. Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  6. Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  7. Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  8. Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

    Time frame: Baseline before DBS implant

  14. 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

    Time frame: 24 months after start of DBS

  15. 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

    Time frame: Baseline before DBS is turned off

  16. 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

    Time frame: 72 hours after DBS is turned off

  17. 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

    Time frame: During DBS placement surgery before active DBS

  18. 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

    Time frame: During DBS placement surgery during active DBS

  19. Spectral power recorded during intraoperative electrocorticography (ECoG)

    Time frame: During DBS placement surgery before active DBS

  20. Spectral power recorded during intraoperative electrocorticography (ECoG)

    Time frame: During DBS placement surgery during active DBS

Secondary outcomes

  1. 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).

    Time frame: Baseline before DBS implant

  2. 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).

    Time frame: 24 months after start of DBS

  3. 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).

    Time frame: Baseline before DBS is turned off

  4. 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).

    Time frame: 72 hours after DBS is turned off

  5. Tremor amplitude as assessed by accelerometric power

    Time frame: Baseline before DBS is turned off

  6. Tremor amplitude as assessed by accelerometric power

    Time frame: 72 hours after DBS is turned off

07

Study locations

1 of 1 sites recruiting
  • North Shore University Hospital
    Manhasset, New York 11030, United States
    Recruiting
    • Albert Fenoy · Contact
    • Prashin Unadkat · Sub investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2021 (actual). Primary completion is estimated for Aug 2027, 68 months after the start.

Of 77 non-industry interventional studies with no phase under Essential Tremor, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 26. This study's planned 68 months is above that.

Counting every sponsor, half of 95 studies reached it within 45 months; a quarter within 19 and three quarters within 93.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Aug 2026 → Aug 2027 and completion Aug 2026 → Aug 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2021
First posted
Feb 17, 2021
StartActual
Dec 4, 2021
Primary completionEst.
Aug 31, 2027was Aug 2026
CompletionEst.
Aug 31, 2027was Aug 2026
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 31, 2026→Aug 31, 2027
Sep 29, 2026
Study completion
Aug 31, 2026→Aug 31, 2027
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Primary completion Aug 31, 2026→Aug 31, 2027
    Study completion Aug 31, 2026→Aug 31, 2027
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04758624
Lead sponsor
Northwell Health
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Feb 17, 2021
Start date
Dec 4, 2021
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Mark Amandola
Contact
mamandola@northwell.edu
516 491 1054
Albert J Fenoy, MD
principal investigator · Northwell Health

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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