Wearable Sensor for Responsive DBS for ET
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 3/3/2019 |
| Start Date: | September 18, 2018 |
| End Date: | December 1, 2020 |
| Contact: | Aysegul Gunduz, PhD |
| Email: | agunduz@ufl.edu |
| Phone: | 3522736877 |
Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor
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.
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.
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.
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.
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.
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