directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor (NCT05795218) | Clinical Trial Compass
TerminatedNot Applicable
directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor
Stopped: Insolvency of the business
Germany21 participantsStarted 2021-06-21
Plain-language summary
This is a prospective, multi-center, single arm post-market clinical follow-up study.
The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care.
This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system.
Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria.
Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors.
After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care.
Study will be conducted at minimum 3 centers in Europe.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is 18 years of age or older.
* Patient with main tremor symptoms in upper limbs.
* Patient was referred for DBS surgery to treat Essential Tremor and chose the directSTIM DBS System
* Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor with medication, for the worst limb (i.e. most affected by disease)
* Patient accepts to abstain from caffeine for 8 hours and from alcohol for 12 hours before visit.
* Patient accepts to turn stimulation off for 1 hour prior to the 3-month follow-up visit.
* Patient is willing to provide a written informed consent.
* Patient is available for the study visit, and other study requirements.
Exclusion Criteria:
* Cognitive impairment, or any characteristic that would limit study candidate's ability to complete study assessments, such as:
* Active major psychiatric disorder (including clinically significant depression as rated by the clinician)
* Patient had dementia interfering with their ability to co-operate or comply with study requirements or comprehend the informed consent (mini-mental exam score \<24 or otherwise not capable of discernment)
* Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker)
* Previous brain ablation/surgical procedure
* Neurological injury, evidence of supraspinal central nervous system disease
* History of seizures
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb