| NCT ID | NCT06148324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2024-04-11 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI). Participants will be randomized at enrollment into two groups: immediate treatment (IT) and delayed treatment (DT) group. This study will also provide insights into the impact of these intervention's components in helping emotional, physical, and nutritional outcomes post-injury in the context of social determinants of health (SDOH).
Eligibility Criteria
Inclusion Criteria: * Have a medically-documented (e.g., EMS report, hospital record, physician record) or per medical monitor review complicated-mild, moderate, or severe TBI requiring admission to an acute inpatient rehabilitation unit * Be at least 12 months post-TBI * Have access to the internet on a computer, tablet, and/or smartphone. * Speak and understand English or Spanish * Agree to participate * Are medically cleared by their primary physician, physiatrist, neurologist, rehabilitation therapist, or other recognized health professional to participate in the study Exclusion Criteria: * No history of complicated-mild, moderate, or severe TBI * Less than 12 months post-TBI * In minimally conscious or vegetative state * Beginning a new treatment regimen (e.g., physical therapy, occupational therapy, vestibular therapy, psychotherapy, and/or medication) at study start that can influence study findings in the judgment of the principal investigator and/or medical monitor (participants whose treatment regimens are stable will be eligible) * In the judgment of the principal investigator, medical monitor, and/or study team member, presence of significant cognitive impairment (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection * In the judgment of the principal investigator, medical monitor, and/or study team member, significant or major disabling medical condition sufficient to preclude meaningful informed consent and/or data collection
Contact & Investigator
Tamara Bushnik, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06148324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06148324 currently recruiting?
Yes, NCT06148324 is actively recruiting participants. Contact the research team at Fatima.Imdad@nyulangone.org for enrollment information.
Where is the NCT06148324 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06148324 clinical trial?
NCT06148324 is sponsored by NYU Langone Health. The principal investigator is Tamara Bushnik, PhD at NYU Langone Health. The trial plans to enroll 138 participants.