Wearable Sensor for Responsive DBS for ET

NCT ID: NCT03051178

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2021-09-29

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.

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.

Conditions

Essential Tremor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Responsive deep brain stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

De Luca Foundation

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aysegul Gunduz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

Biomedical Sciences Building

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OCR17477

Identifier Type: OTHER

Identifier Source: secondary_id

1F31NS115363-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UH3NS095553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201602458 -A

Identifier Type: -

Identifier Source: org_study_id