Wearable Sensor for Responsive DBS for ET

Essential Tremor Clinical Trial

Official title:

Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051178
• Other study ID #: IRB201602458 -A
• Secondary ID: OCR174771F31NS11
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: September 29, 2021

Study information

• Verified date: October 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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.

Locations

Country	Name	City	State
United States	Biomedical Sciences Building	Gainesville	Florida
United States	UF Health	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	De Luca Foundation, Medtronic, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Rating Scale for Tremor (CRST)	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.	30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized.