NCT02678429

Brief Summary

Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 27, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

5.2 years

First QC Date

February 5, 2016

Results QC Date

November 30, 2022

Last Update Submit

March 24, 2023

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

  • Fahn-Tolusa-Marsden Tremor Rating Scale

    Tremor quantification

    1 month

Study Arms (2)

DBS programming, standard of care

ACTIVE COMPARATOR

DBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas

Device: Change DBS programming

DBS progamming from Atlas

EXPERIMENTAL

DBS settings determined from the a functional atlas first then change to settings determined by standard of care

Device: Change DBS programming

Interventions

Change DBS programmingDEVICE

Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing

DBS progamming from AtlasDBS programming, standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor

You may not qualify if:

  • Unable to use the patient handheld programmer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

Unable to fully recruit for the study

Results Point of Contact

Title
Fenna Phibbs
Organization
VUMC
fenna.phibbs@vumc.org
614-936-0060

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

September 1, 2016

Primary Completion

November 19, 2021

Study Completion

November 19, 2021

Last Updated

March 27, 2023

Results First Posted

March 27, 2023

Record last verified: 2023-03

Locations

US(1)