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Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor

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ClinicalTrials.gov Identifier: NCT04212780
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Medtronic
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This is a feasibility study based on physician-initiated Investigational Device Exemption (IDE) including intraoperative experiments and chronic testing of implanted dual thalamic DBS lead systems. This study will inform protocols for optimal use of implanted next-gen DBS systems for primarily tremor control in refractory essential tremor.If the approach appears to be successful, the pilot data generated will be used to base a future pivotal trial for FDA approval for enhanced tremor control and adaptive DBS (aDBS) functionality of DBS systems.

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Medtronic Summit Rechargable (RC)+S Procedure: ipsilateral thalamic (VIM+VO) DBS Procedure: standard ET DBS Procedure: ipsilateral VO Not Applicable

Detailed Description:

Ventralis intermedius nucleus of the thalamus (VIM) Deep Brain Stimulation (DBS) has emerged as a highly effective treatment for essential tremor, which is an incurable, degenerative brain disorder that results in progressively debilitating tremor, afflicting an estimated 7 million people in the US (2.2% of the population). Clinical observation shows, however, that disease progression results in eventual recurrence of debilitating tremor in 10 to 20% of VIM DBS patients. DBS revision surgery, with replacement of sub-optimally positioned VIM DBS leads and addition of an ipsilateral ventralis oralis (VO) DBS lead, has emerged as an effective rescue strategy for many such patients with delayed failure of VIM DBS therapy.

Since essential tremors are typically not continuous, tremor suppressing DBS therapy need not necessarily be delivered continuously and could theoretically be effective if delivered only when movement intent or tremor is present.

Our central hypothesis is that a VIM+VO DBS system capable of detecting the neurophysiologic markers of essential tremor (ET) associated with goal directed movements, and providing responsive dual lead thalamic stimulation in a targeted and personalized manner, would provide improved suppression of severe tremor, reduce adverse effects associated with continuous stimulation, and prolong the battery life of the implantable neurostimulator (INS), decreasing the frequency of surgical procedures necessary to replace devices with depleted batteries.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor
Actual Study Start Date : December 24, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Active Comparator: Treatment Naive
Participants receiving Long-term stimulation of the thalamus via dual leads for Essential Tremor
Device: Medtronic Summit Rechargable (RC)+S
Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO

Procedure: standard ET DBS
Single Lead VIM

Procedure: ipsilateral VO
second lead in the ipsilateral VO

Active Comparator: Refractory Participants
Patients with recurrent, debilitating intention tremor despite ongoing, optimized VIM DBS therapy
Device: Medtronic Summit Rechargable (RC)+S
Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO

Procedure: ipsilateral thalamic (VIM+VO) DBS
Implantation of two new ipsilateral thalamic (VIM+VO) DBS




Primary Outcome Measures :
  1. Efficacy Assessment - Tremor [ Time Frame: Up to 24 months ]
    Tremor rating scale This 5-point scale rates tremor severity based on tremor amplitude, from 0 (no tremor) to 4 (severe tremor) in each part of the body, and includes assessments of specific abilities and functional disability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient gives an informed consent.
  • Patient is over 21 years of age.
  • Patient is diagnosed with a postural-intention (essential) tremor for at least 3 years, meets diagnostic criteria for ET, has been evaluated and examined by a movement disorders fellowship trained neurologist, and is being treated with traditional VIM DBS therapy.
  • Patient has no evidence of non-ET central nervous system disease or injury and has had a significantly disabling, upper extremity tremor despite ongoing VIM DBS therapy for at least three (3) months prior to DBS revision surgery.
  • Patient has a postural or kinetic tremor severity score of at least 2 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (TRS) despite ongoing VIM DBS therapy.
  • Patient has a TRS score of 2 or above in any one of the items 16-23 from the Disability subsection of the TRS: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working and social activities despite ongoing VIM DBS therapy.
  • Patient's tremor is refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
  • Patient is available for appropriate follow-up times for the length of the study

Exclusion Criteria:

  • Any previous neurosurgical intervention other than VIM DBS, including ablative brain lesions for tremor suppression.
  • Medication related movement disorders.
  • Any suspicion of Parkinson's disease, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.
  • Any behaviors consistent with alcohol or substance abuse as defined by the criteria outlined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V).
  • Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, continuous neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians.
  • Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating lesions, or infectious lesions. Also excluded will be subjects with severe brain atrophy.
  • Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).
  • A history of seizures within the past year.
  • A dementia rating scale score (DRS) <130 signifying significant cognitive dysfunction and a potential for inability to cooperate with tasks involved in the study.
  • Any attempt or intent of suicide during the previous six months.
  • Presence or history of psychosis.
  • Significant or active mood disorders including depression. For the purpose of this study, we consider a significant mood disorder to include any subject who has:

    • Scores ≥ 20 on the Patient Health Questionnaire - 9 (PHQ-9).
    • Currently under the care of a psychiatrist
    • Currently participating in cognitive-behavioral therapy
    • Been hospitalized for the treatment of a psychiatric illness within 12 months
    • Ever received transcranial magnetic stimulation
    • Ever received electroconvulsive therapy
  • In addition, patients who are pregnant or plan to become pregnant will be excluded from this study.

Information from the National Library of Medicine

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): NCT04212780


Contacts
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Contact: Cami Swartz 352-733-2429 cami.swartz@neurology.ufl.edu
Contact: Karim Oweiss, PhD 352-294-1898 koweiss@ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
Medtronic
Investigators
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Principal Investigator: Karin Oweiss, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04212780    
Other Study ID Numbers: IRB201901021
OCR29622 ( Other Identifier: University of Florida )
1UH3NS109845-01 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases