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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT06104735
Eligibility Criteria:
Inclusion Criteria:
* Age between 18-85 years.
* Must have stable prescription medication for 30 days prior to screening
* Must be able to: abstain from alcohol, smoking and heavy caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 53 visits); provide informed consent.
* Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.
Exclusion Criteria:
* Personal or extensive family history of seizures;
* Ventilator dependence or patent tracheostomy site;
* History of stroke, brain tumor, brain abscess, or multiple sclerosis;
* History of severe head trauma requiring neurosurgery;
* History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;
* Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV;
* Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
* History of significant hearing problems;
* History of bipolar disorder;
* History of suicide attempt;
* Active psychosis;
* Recent history (\>1 year) of chemical substance dependency or significant psychosocial disturbance;
* Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;
* Open skin lesions over the face, neck, shoulders, or arms;
* Pregnancy; and
* Unsuitable for study participation as determined by study physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06104735
Study Brief:
Protocol Section:
NCT06104735