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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation(DBS) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | |
| Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI | 24 months after start of DBS | |
| Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | |
| Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI | 24 months after start of DBS | |
| Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | |
| Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI | 24 months after start of DBS | |
| Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI | Baseline before DBS implant | |
| Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline before DBS implant |
| Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Amandola | Contact | 516 491 1054 | mamandola@northwell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Albert J Fenoy, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Recruiting | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38237402 | Result | 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. |
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| Baseline before DBS implant |
| Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | During DBS placement surgery during active DBS |
| Spectral power recorded during intraoperative electrocorticography (ECoG) | During DBS placement surgery before active DBS |
| Spectral power recorded during intraoperative electrocorticography (ECoG) | During DBS placement surgery during active DBS |
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). |
| 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). | 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). | 72 hours after DBS is turned off |
| Tremor amplitude as assessed by accelerometric power | Baseline before DBS is turned off |
| Tremor amplitude as assessed by accelerometric power | 72 hours after DBS is turned off |
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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