Coordinated Reset Deep Brain Stimulation for Essential Tremor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Minnesota
About this trial
Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation. This study will evaluate the feasibility, safety and short-term efficacy of thalamic CR-DBS in upper extremity ET. The goal of this study is to evaluate the safety and short-term efficacy of thalamic CR- DBS in ET, including the acute (during CR-DBS) and carryover (following DBS cessation) effects, and compare these to those induced by clinically optimized T-DBS. To achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (UE) ET. The first aim is to identify the spatial location and peak frequency of tremor related oscillatory activities in VIM (Phase I). The second aim is to compare the acute effects of thalamic CR-DBS to clinically optimized T-DBS (Phase II).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of essential tremor (ET)
Age of 21 or over
Will be or has been 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"
Disqualifiers
History of musculoskeletal disorders that affect movement of the limbs or gait
Other significant neurological disorder
History of dementia or cognitive impairment that precludes them from getting DBS surgery
Significant psychiatric disease
Trial design
Design model
Crossover
Treatments tested in this trial
Deep brain stimulation
DeviceThalamic 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.
Treatment groups
23 Participants
are divided into 2 treatment groupsGroup A: Coordinated Reset DBS Setting (CR-DBS)Experimental treatment 1 intervention
Group B: Clinically Optimized DBS Setting (T-DBS)Other 1 intervention
Trial outcomes
Primary outcomes
1
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
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.
Time frame
4 monthsSecondary outcomes
1
Instrumented Tremor Measurement
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.
Time frame
4 months2
Bain Tremor Disability Scale (BTDS)
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.
Time frame
4 months3
Quality of Life in Essential Tremor (QUEST)
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.
Time frame
4 months4
Quantitative Archimedes Spirals
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.
Time frame
4 monthsSponsors and contacts
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Source ClinicalTrials.gov