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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNorthwell Health

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Deep Brain Stimulation

    Device

    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.

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: Deep Brain Stimulation(DBS)Experimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

National Institutes of Health (NIH)

Collaborator