- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05897775
Coordinated Reset Deep Brain Stimulation for Essential Tremor
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jing Wang, PhD
- Phone Number: (612) 626-6071
- Email: wang3444@umn.edu
Study Contact Backup
- Name: Peter Grund
- Phone Number: 612-624-6434
- Email: grund130@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Jing Wang, PhD
- Phone Number: 612-626-6071
- Email: wang3444@umn.edu
-
Contact:
- Peter M Grund, BS
- Phone Number: 612-624-6434
- Email: grund130@umn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Essential Tremor (ET)
- Age of 21 or over
- Will be implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
- 7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's (Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging of DBS targets at 7T MRI"
- Planned post-operative CT scan
Exclusion Criteria:
- History of musculoskeletal disorders that affect movement of the limbs or gait
- Other significant neurological disorder
- History of dementia or cognitive impairment (Mini-Mental Score < 26)
- Significant psychiatric disease
- On medication that could cause tremor
- Prior brain surgery
- Pregnant women
- Evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation
- Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
- Other significant medical disorder that could impede study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coordinated Reset DBS Setting (CR-DBS)
Coordinated Reset DBS settings
|
Thalamic coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude, high frequency stimulation. Each participant will receive both the new intervention and the standard of care intervention, each for a week. |
Other: Clinically Optimized DBS Setting (T-DBS)
Traditional DBS settings
|
Thalamic coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude, high frequency stimulation. Each participant will receive both the new intervention and the standard of care intervention, each for a week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
Time Frame: 4 months
|
TETRAS is a rating scale introduced by the Tremor Research Group which has undergone extensive performance evaluations7. The TETRAS Activities of Daily Living Subscale (TETRAS-ADL) rates tremor's impact on activities of daily living, using 12 test items with each item scored from 0-4 (increasing with severity). The TETRAS-ADL total score range is 0-48. The TETRAS performance subscale (TETRAS-P) consists of 16 scored items designed to measure essential tremor of the head, face, voice, upper extremity, lower extremity and trunk, with each item scored from 0-4 (increasing with severity). Specific amplitude measurements are used to guide the ratings for each item. Tasks of spiral drawing, handwriting and object holding are included. The TETRAS-P total score range is 0-64. The total TETRAS score, including both TETRAS-ADL and TETRAS-P, ranges from 0 to 112. |
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Instrumented Tremor Measurement
Time Frame: 4 months
|
Quantitative measurements of upper extremity tremor can add power to clinical treatment trials 10,11 .
Inertial measurement units (IMU) are lightweight, wearable motion sensors that offer a reliable means for the objective measurement of tremor 12 .
In this trial Delsys IMU's will provide a secondary measure of tremor amplitude using recordings from a built-in accelerometer and gyroscope.
IMU's will be attached to the arm muscles and recordings will be made during the upper extremity postural and action tasks of the TETRAS-P assessment, without adding additional assessment time.
|
4 months
|
Bain Tremor Disability Scale (BTDS)
Time Frame: 4 months
|
The Bain Findlay Tremor Activities of Daily Living scale is a 25-item self-administered questionnaire assessing items related to eating, hygiene, writing and other daily tasks (item rating 1-4, total score 25-100, increasing with severity).
The scale is reliable in test-retest measures, although the correlation of disability scores to tremor amplitude measurements is not established.
|
4 months
|
Quality of Life in Essential Tremor (QUEST)
Time Frame: 4 months
|
QUEST is a quality of life measure specifically designed for essential tremor .
The scale is a self-administered questionnaire of 30 items clustering around five factors: Physical, Psychosocial, Communication, Hobbies/Leisure, and Work/Finance.
QUEST has good reliability (intraclass correlation coefficient >=.89) and correlates best with overall quality of life measures rather than upper extremity tremor severity.
|
4 months
|
Quantitative Archimedes Spirals
Time Frame: 4 months
|
Visual ratings of Archimedes Spiral drawing provide one of the most sensitive measures of tremor.
Recording the spiral drawing on a digitizing tablet increases the sensitivity of tremor detection and can replace or augment clinical tremor measures.
In this trial, patients will draw spirals on a Windows Surface tablet to obtain a quantitative measure of upper extremity tremor severity.
The drawn spirals will be analyzed in MATLAB to output a score which correlates to severity of tremor.
|
4 months
|
Dot Approximation Task
Time Frame: 4 months
|
Subject will hold a pen/stylus above a dot on a white sheet of paper for ~10 seconds and try to keep the tip of the pen/stylus as close as possible to the dot without touching it.
A MBIENTLAB IMU sensor will be wrapped around the middle finger to assess tremor.
Data from the sensor will be logged in the tablet and analyzed in MATLAB to output a score.
This task is a testing item in the TETRAS-P7.
While TETRAS is challenging to assess remotely, the Dot Approximation Task is easy to perform and provides a sensitive, quantitative measure of tremor.
Both the Quantitative Archimedes Spirals and Dot Approximation Tasks will be used for at-home self-assessment of tremor.
|
4 months
|
Brief Ataxia Rating Scale (BARS)
Time Frame: 2 months
|
The BARS was developed as a short screening instrument to rate cerebellar function in five realms: Gait, Kinetic Function-Arm, Kinetic Function-Leg, Speech, and Eye Movements.
The scale is reliable (intraclass correlation coefficient = .91),
internally consistent and correlates highly with other more detailed scales.
The scale can be administered in minutes making it ideal for repeated assessment of dysfunction in cerebellothalamic pathways.
|
2 months
|
Quantitative Gait Analysis
Time Frame: 2 months
|
Gait ataxia is another common side-effect of DBS for ET.
Marker-less pose estimation will be used to obtain a quantitative measure of gait ataxia by tracking the joints while the subject walks in a heel-to-toe, or tandem, manner.
This data will be analyzed using DeepLabCut in Matlab to compute parameters such as midline deviation, gait speed, and wrist sway.
Increased midline deviation and/or missteps, and a decrease in tandem gait speed will indicate gait ataxia.
|
2 months
|
Quantitative Speech Analysis
Time Frame: 2 months
|
Stimulation-induced dysarthria is a common side effect of DBS for ET.
In this trial, speech tasks will be recorded and analyzed to compute several parameters.
During the speech recording, the subject will perform the oral diadochokinesis task by repeating the syllables /ka/, /pa/, or /ta/ ten times each recruiting a different structure of articulation.
These recordings will be analyzed using PRAAT (http://www.praat.org/)
and custom MATLAB scripts to compute the voice duration and voice onset time.
Prolonged voicing and decreased VOT are indicators of stimulation-induced dysarthria.
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jing Wang, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-DBS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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