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:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT05456451
Eligibility Criteria:
Inclusion Criteria:
* Being between the ages of 40-65.
* Diagnosed with Parkinson's Disease by a specialist neurologist.
* Hoehn-Yahr stage 2-3.
* Having bilateral resting tremor of the hands.
* Being agreed to participate in the study.
Exclusion Criteria:
* Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
* Severe depression (Beck Depression Scale \> 29)
* Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
* Pregnancy or planning to become pregnant or breast-feed during the study period.
* Botox injections or any other upper extremity rehabilitation within 6 months prior to treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT05456451
Study Brief:
Protocol Section:
NCT05456451