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Wearable Sensor for Responsive DBS for ET

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ClinicalTrials.gov Identifier: NCT03051178
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : October 28, 2022
Last Update Posted : November 22, 2022
Sponsor:
Collaborators:
Medtronic
De Luca Foundation
National Institute of Neurological Disorders and Stroke (NINDS)
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)
Actual Enrollment : 17 participants
Allocation: N/A
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
Actual Primary Completion Date : September 29, 2021
Actual Study Completion Date : September 29, 2021

Resource links provided by the National Library of Medicine


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: 30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized. ]
    Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation. Clinical Tremor Rating Scale (TRS), rated by a blinded neurologist, during responsive brain stimulation will be compared to scores during continuous deep brain stimulation and no stimulation. The minimum and maximum score range for this scale is 0-80, with higher score indicating worse outcome.



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 is over 21 years of age
  • 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, PC, or RC device.
  • Patient receives Vim electrode and Activa SC, PC or RC device implants, and recovers fully after surgery.
  • 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


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32610
Biomedical Sciences Building
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Medtronic
De Luca Foundation
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Aysegul Gunduz, PhD University of Florida
  Study Documents (Full-Text)

Documents provided by University of Florida:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03051178    
Other Study ID Numbers: IRB201602458 -A
OCR17477 ( Other Identifier: UF OnCore )
1F31NS115363-01A1 ( U.S. NIH Grant/Contract )
UH3NS095553 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2017    Key Record Dates
Results First Posted: October 28, 2022
Last Update Posted: November 22, 2022
Last Verified: October 2022
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
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
Movement Disorders
Central Nervous System Diseases