NCT03051178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 18, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 28, 2022

Completed
Last Updated

April 19, 2024

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

February 9, 2017

Results QC Date

September 8, 2022

Last Update Submit

April 17, 2024

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Subjects with Essential Tremor

EXPERIMENTAL

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

Interventions

Responsive deep brain stimulationDEVICE

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.

Subjects with Essential Tremor

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health

Gainesville, Florida, 32610, United States

Location

Biomedical Sciences Building

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Dr. Aysegul Gunduz
Organization
University of Florida
agunduz@bme.ufl.edu
3522736877

Study Officials

  • Aysegul Gunduz, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

September 18, 2018

Primary Completion

September 29, 2021

Study Completion

September 29, 2021

Last Updated

April 19, 2024

Results First Posted

October 28, 2022

Record last verified: 2022-10

Locations

US(2)