Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT05795218
Eligibility Criteria:
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
* Diathermy
* Abuse of drugs or alcohol.
* Patient had botulinum toxin injection less than 6 months prior to enrollment
* Patient is participating in another clinical study that would confound data analysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05795218
Study Brief:
Protocol Section:
NCT05795218