Responsive Deep Brain Stimulator for Essential Tremor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02649166|
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: Deep brain stimulation Device: Closed-loop deep brain stimulation||Not Applicable|
The purpose of this study is to investigate brain signals related to intention tremor in essential tremor in order to deliver deep brain stimulation only when the patient is showing symptoms. By delivering stimulation only when needed, the investigators hypothesize that the treatment will be more effective, will cause fewer adverse side effects and will increase battery time of the device (reducing the number of battery replacement surgeries).
Participation in this study will require extensive pre-surgical screening to determine eligibility for deep brain stimulation surgery, a deep brain stimulation surgical procedure, and regular follow-ups. Subjects will be seen monthly post surgery for 6 months. After 6 months, data will be assessed and closed-loop deep brain stimulation may be offered as a stimulation setting. If so, the stimulator settings will be changed from chronic to responsive. If not, the subject will continue to receive chronic deep brain stimulation stimulation. Subsequent visits will be scheduled every 6 months until a total of 24 months of study participation (also at month 9).
At the end of the initial 24-month study period, subjects will have the choice of 1) continuing active stimulation at the current setting, 2) continuing stimulation but searching for a new setting, 3) discontinuing stimulation (turning the device off), 4) having the device removed. If the subject continues to receive active stimulation, they will be followed by the investigators and seen at yearly intervals.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Deep brain stimulation
All participants will undergo unilateral deep brain stimulation (DBS) implantation for essential tremor. Medtronic Summit RC+S devices will be used because these are capable of recording brain signals, as well as delivering DBS. Participants will receive continuous (open-loop) and closed-loop deep brain stimulation interventions, which will be compared for efficacy.
Device: Deep brain stimulation
The deep brain stimulation system includes an implantable neurostimulator, thalamic leads to be implanted in the ventral intermediate nucleus (Vim), and subdural cortical strips. The deep brain stimulation system will be set to provide continuous stimulation for the 6 months following surgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for deep brain stimulation. At 6 months, the investigators will determine whether or not the subject is a candidate for closed-loop deep brain stimulation. Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. These subjects will been seen every 6 months for evaluation as part of normal clinical care for deep brain stimulation.
Other Name: Medtronic Summit RC+S
Device: Closed-loop deep brain stimulation
The deep brain stimulation system includes an implantable neurostimulator, Vim thalamic leads, and subdural strips. Six months post-surgery, the deep brain stimulation system will be set to provide responsive stimulation for the duration of the study. Subjects will be seen every 6 months for evaluation as a part of normal clinical care for deep brain stimulation. Data gathered from the subject during the first 6 months will be used to determine if this intervention is applicable for each individual subject. Subjects who do not qualify will continue to receive the other study intervention.
Other Name: Medtronic Nexus-E
- Clinical Rating Scale for Tremor (CRST) for continuous deep brain stimulation [ Time Frame: 6 months post-surgery ]
- Reduction in Clinical Rating Scale for Tremor after 6 months as an effect of continuous Vim deep brain stimulation
The Fahn-Tolosa-Marin Tremor Rating Scale is a clinical rating scale assessing severity of tremor by body part from 0 (none) to 4 (severe). The scale is divided into three parts, where Part A assesses tremor severity at rest, during posture, and kinetic maneuvers for nine body parts; Part B assesses ability to perform specific motor tasks/functions (writing, drawing, and pouring with dominant and nondominant hands); and Part C assesses patient-reported functional disability resulting from the tremor. Score ranges from 0 to 80 for Part A, from 0 to 36 for Part B, and from 0 to 28 for Part C. The total score obtained by adding the three parts is 144. A higher score indicates a higher severity of the tremor. Finally, the scale includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.
- Clinical Rating Scale for Tremor (CRST) for closed-loop deep brain stimulation [ Time Frame: Baseline until 24 months post-surgery ]
- Closed-loop deep brain stimulation as an effective alternative to continuous deep brain stimulation
Clinical scores during continuous stimulation will be compared to scores on the during closed-loop stimulation.
- Clinical Rating Scale for Tremor (CRST) for continuous deep brain stimulation [ Time Frame: 24 months post-surgery ]- Reduction in Clinical Rating Scale for Tremor after 24 months as an effect of continuous Vim deep brain stimulation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649166
|Contact: Aysegul Gunduz, Ph.Demail@example.com|
|Contact: Julie Segurafirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Aysegul Gunduz, PhD 352-273-6877 email@example.com|
|Principal Investigator:||Aysegul Gunduz, Ph.D||University of Florida|