Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT07302867
Brief Summary:
The goal of this observational study is to learn whether a new way of programming Deep Brain Stimulation (DBS) can improve and maintain tremor control in adults with essential tremor (ET) who stopped responding to standard DBS therapy.
The main questions it aims to answer are:
* 1\. Can advanced DBS settings, using varied stimulation patterns, frequencies, and pulses, restore tremor control in people with ET who lost benefit from standard Ventral Intermedius Deep Brain Stimulation (VIM-DBS)?
* 2\. Do these advanced settings provide more stable, longer-lasting tremor improvement over time?
Researchers will compare six different stimulation settings to see if any of them can improve tremor symptoms when standard DBS programming no longer works.
Participants will:
* Complete a clinic visit where they try six different DBS stimulation settings using specialized Chronos software.
* Be randomly assigned to one of these settings to use at home.
* Receive a follow-up phone call at 4 weeks to check on symptoms and device use.
* Return to the clinic at 3 months for a full tremor evaluation.
* Have the option to return for an additional follow-up visit at 1 year.
This study will include 5 participants with essential tremor who previously lost benefit quickly after receiving standard VIM-DBS treatment.
Detailed Description:
* Purpose: To test whether new DBS programming patterns can restore and sustain tremor control in essential tremor (ET) patients who lose benefit quickly after standard Vim-DBS.
* Hypothesis: Novel stimulation paradigms - like high-frequency, microburst, cycling, and scheduling - can overcome early habituation and provide lasting tremor improvement.
* Justification: Some ET patients experience rapid loss of benefit despite correct DBS placement. Standard programming does not help them, creating a disabling condition. Advanced programming may offer a safe, non-surgical solution.
* Objectives:
* 1\. Determine if Chronos™ software programs maintain tremor improvement beyond one month.
* 2\. Assess safety, tolerability, and identify the most effective stimulation parameters.
* Research Design: Prospective, single-center cohort study of 5 early-habituating ET patients. Patients trial six stimulation paradigms in clinic, then are randomized to one program for home use. Follow-up occurs at 4 weeks, 3 months, and optionally 1 year.
* Statistical Analysis: Descriptive statistics due to small sample size. Outcomes include tremor ratings, patient-reported benefit, and recurrence of habituation.
Study:
NCT07302867
Study Brief:
Protocol Section:
NCT07302867