Algorithms for Programming DBS Systems for Essential Tremor
This study is testing new ways to program Deep Brain Stimulation (DBS) systems for people with Essential Tremor (ET). DBS uses a device to send electrical signals to a part of your brain called the Vim thalamus to help with tremors. Currently, finding the best settings can take a lot of time. This research uses computer models to help doctors more efficiently find the best settings for your specific brain. The goal is to improve how well DBS works and make the process easier. You may be able to join if you have ET, your tremor isn't controlled by medication, and you already have a VIM-DBS implant. Success will be measured by how well tremors are controlled and your quality of life after 24 months.
- Study design
- This interventional study plans to enroll 25 participants. It is testing additional model-derived DBS settings.
- What's involved
- You would have initial and regular follow-up clinical visits every 6 months for up to 2 years. During these visits, your DBS settings would be re-evaluated.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months, with tremor and quality of life measured at this time point.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Algorithms for Programming DBS Systems for ET
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Therapeutic Windows24-months
Quantify how therapeutic windows (i.e. stimulus amplitude threshold difference between postural and action tremor abolishment and side effect emergence) change over time with human Vim-DBS therapy. During routine clinical evaluation sessions, monopolar stimulation will be applied through each electrode to generate therapeutic window maps and quantify the degree to which stimulus amplitude thresholds for action and postural tremor abolishment and for generating side effects of stimulation (e.g. transient paresthesias) change.
- Objective Measures of Tremor24-months
Quantify tasks contained in the Essential Tremor Rating Assessment Scale (TETRAS) scoring system. Inertial measurement units (IMUs) will be attached to the limbs and head of the subject to measure tremor while the subject performs tasks associated with the TETRAS scoring scale. The Archimedes spiral task contained in the TETRAS will be quantified by using a digitizing tablet.
- Quality of Life Questionnaire: QUEST24-months
The Quality of life in Essential Tremor Questionnaire (QUEST) questionnaire consists of 30 items that are rated from 0 (never) to 4 (always), corresponding to the frequency with which tremor is perceived to impact function or to be associated with various feelings and attitudes. The 30 items contribute to five sub scales: Physical/ADL, Psychosocial, Communication, Hobbies/Leisure, and Work/Finances. Each sub scale score is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain. Total score is computed by calculating the mean of the five sub scale scores. Higher score indicates greater disability.
- Quality of Life Questionnaire: TETRAS24-months
The Essential Tremor Rating Assessment Scale (TETRAS) quantifies the impact of essential tremor (ET) on activities of daily living (ADL) and a performance battery. The ADL section consists of 12 items rating the impact of ET on daily activity, each rated 0 (normal) to 4 (severe), with a maximum subscale score of 48. The performance section has 9 items rating action tremor in different areas of the body from 0 (normal) to 4 (severe), with a maximum subscale score of 64. Total score is an unweighted sum of the two subscale scores. Greater total score indicates worse functioning due to ET.