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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT03288220
Eligibility Criteria:
* INCLUSION CRITERIA:
* Healthy younger adults:
* Ages 18 years to less than 50 years. (18 to 49)
* Willingness/ability to provide informed consent.
* Ability to induce a motor evoked potential in the muscle target of the upper extremity, as evaluated during the TMS Screening.
* Healthy older adults:
* Age 50 and over
* Willingness/ability to provide informed consent.
* Ability to induce a motor evoked potential in the muscle target of the upper extremity, as evaluated during the TMS Screening.
* Stroke patients:
* Age 18 and over.
* Unilateral or bilateral upper limb paresis with the ability to voluntarily contract a finger, hand, wrist, or elbow muscle in the affected arm(s).
* Stroke onset \> 6 months prior to participation.
* Intact M1 sufficient to induce motor evoked potentials in the affected upper extremity following ipsilesional TMS, as evaluated during the TMS Screening.
* Willingness/ability to provide informed consent.
* If the investigator feels the individual s capacity to provide informed consent is questionable, the NIH Human Subjects Protection Unit (HSPU) will be requested to determine the individual s ability to consent.
EXCLUSION CRITERIA:
* Healthy younger and older adults:
* Presence of severe neurological or medical disorder (e.g., Parkinson s disease or multiple sclerosis).
* History of seizures.
* Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), tri-cyclic or other anti-depressants, benzodiazepines, or prescription stimulants.
* TMS contraindications, such as:
* Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside the eye or skull.
* Diagnosed severe hearing loss.
* Current pregnancy.
* Staff from our section.
* Stroke patients:
* Presence of severe neurological or medical disorder, other than stroke (e.g., Parkinson s disease or multiple sclerosis).
* History of brainstem stroke.
* History of seizures.
* Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), benzodiazepines, or prescription stimulants.
* TMS contraindications, such as:
* Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside
the eye or skull.
---Diagnosed severe hearing loss.
* Current pregnancy.
* Staff from our section.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03288220
Study Brief:
Protocol Section:
NCT03288220