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Wearable Sensor for Responsive DBS for ET

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ClinicalTrials.gov Identifier: NCT03051178
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
Medtronic
De Luca Foundation
Information provided by (Responsible Party):
University of Florida

Brief Summary:

The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography (EMG). This therapy is called Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer, and apply stimulation when the computer detects patterns associated with tremor. This detection will suppress pathological activity and improve or alleviate the tremor.

Currently, DBS is approved for the treatment of ET; however, stimulation is delivered continuously even when tremor or other symptoms are absent. Continuous DBS can lead to unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS will turn on only if activity associated with ET from the external sensors is detected.


Condition or disease Intervention/treatment Phase
Essential Tremor Device: Responsive deep brain stimulation Not Applicable

Detailed Description:
The overall purpose of this application is to capture pathological activity related to essential tremor using external wearable sensors to responsively initiate or terminate DBS. To this end, the researchers propose to use the Nexus-D system, which requires a firm ware update to an Activa Implantable Neurostimulator (INS), and it will in a smart way turn DBS on/off in patients. The study team will recruit subjects with Activa SC or PC neurostimulator implants during 6 post-operative programming visits. The research group is already familiar with and is in possession of the Nexus-D system, and the investigators have successfully performed responsive DBS in two patients with Tourette syndrome (TS) and in four patients with Parkinson's disease in acute settings. The lab is also equipped with wireless wearable sensor and amplifier systems, such as a 16-unit wireless EMG+ acceleration+inertia Trigno Wireless Bio Acquisition System (Delsys Inc, Natick, MA). The study team aims to combine these signal modalities to capture pathological symptoms and generate commands to initiate or terminate DBS (also record adverse side effects, if any). The project goal is to characterize the clinical efficacy, side effect profile, and battery life of closed-loop DBS in acute settings using wearable sensors in essential tremor patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: Subjects with Essential Tremor
This cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
Device: Responsive deep brain stimulation
Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.




Primary Outcome Measures :
  1. Clinical Rating Scale for Tremor (CRST) [ Time Frame: 6 months post-op ]
    Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation Clinical scores during continuous stimulation will be compared to scores on the during closed-loop stimulation.


Secondary Outcome Measures :
  1. Clinical Rating Scale for Tremor (CRST) [ Time Frame: 12 months post-op ]
    Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation Clinical scores during continuous stimulation will be compared to scores on the during closed-loop stimulation.

  2. Clinical Rating Scale for Tremor (CRST) [ Time Frame: 24 months post-op ]
    Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation Clinical scores during continuous stimulation will be compared to scores on the during closed-loop stimulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide informed consent.
  • Patient has had a significant disabling, medication-refractory upper extremity tremor with no evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation of Activa SC or PC device.
  • Patient receives Vim electrode and Activa SC or PC device implants, and recovers fully after surgery.
  • Patient has had a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (CRST).
  • Patient is available for study participation after their clinical programming appointments for six months.

Exclusion Criteria:

  • Medication related movement disorders.
  • Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.
  • 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.
  • Patient is undergoing a lead revision surgery.

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): NCT03051178


Contacts
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Contact: Aysegul Gunduz, PhD 3522736877 agunduz@ufl.edu
Contact: Julie Segura (352) 273-5566 Julie.Segura@neurology.ufl.edu

Locations
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United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32610
Biomedical Sciences Building Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Medtronic
De Luca Foundation
Investigators
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Principal Investigator: Aysegul Gunduz, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03051178     History of Changes
Other Study ID Numbers: IRB201602458 -A
OCR17477 ( Other Identifier: UF OnCore )
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases