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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07404761
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18-80 years.
2. Clinically confirmed diagnosis of stroke or TBI within the past 12 months.
3. Presence of moderate to severe neuromotor impairment in at least one limb, as evidenced by medical evaluation and a score \<35 on the Fugl-Meyer Upper Extremity motor subscale (FMA-UE).
4. Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.
5. Subject is able to adhere to the study schedule and cognitively capable to perform the treatment.
6. Stable medical condition without ongoing acute complications that could interfere with participation.
Exclusion Criteria:
1. Presence of contraindications to electrical stimulation (ES), including implanted electronic medical devices (e.g., pacemakers, insulin pumps) or conditions that may be exacerbated by electrical stimulation (e.g., uncontrolled epilepsy).
2. Individuals with medical conditions, which are prone to seizures or motion sensitivity, at the investigator's discretion.
3. Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients.
4. Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.
5. Presence of spinal shock or unresolved acute spinal cord dysfunction, characterized by complete loss of reflexes, flaccid paralysis, or autonomic instability.
6. Current participation in other clinical trials that could confound the study results.
7. Severe cognitive impairment that precludes the ability to provide informed consent or reliably adhere to the study protocol, as determined by cognitive screening and clinical judgment.
8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07404761
Study Brief:
Protocol Section:
NCT07404761