NCT06734026 Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
| NCT ID | NCT06734026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MetroHealth Medical Center |
| Condition | Traumatic Brain Injury (TBI) Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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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 20 participants in total. It began in 2025-04-08 with a primary completion date of 2028-01-15.
⚠ 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
The goal of this study is to learn if a enhanced environment (Metro Café) with multi model approach (an approach that combines several therapies) in chronic traumatic brain injury improves outcomes of recovery better than traditional therapy. The main questions it aims to answer are: * Determine the amount of therapy dosage (speech, cognition, arm and leg movements) obtained during the Metro Café therapy session. * Evaluate the connection between environmental enrichment dosage (the Metro Café) and clinical outcome scores. Researchers will compare Metro Café Treatment to those who do not receive this treatment to see if better improvements in function after a traumatic brain injury are seen in the Metro Café Treatment Participants will train in the Metro Cafe during the 2-month gap between assessments, for a total of 18 training sessions, each up to 2 hours, 3 times per week. Participants will greet and serve customers drinks and snacks, maintain food supplies at the counters and performs housekeeping tasks with advice and assistance from a supervising researcher as needed,
Eligibility Criteria
Inclusion Criteria: * moderate to severe neurological diagnosis as diagnosed by a clinician, * ability to comprehend multi step instructions, * ability to independently balance with weight support, * physical deficits resulting in need for additional functional goals, * ability to endure 2 hours of weight-supported standing, * ability to provide informed consent, * basic communication ability, * currently discharged from therapy, * \>3 months post-injury, * \>18 years of age at time of enrollment Exclusion Criteria: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Non-English speaking * Pregnant women * Prisoners * Medical instability * Other neurological conditions * Severe problems with maintaining follow-up expected (such as, but not limited to history of substance abuse, homelessness/incarceration, dementia and psychotic disorders)
Contact & Investigator
James Sulzer, PhD
PRINCIPAL INVESTIGATOR
MetroHealth Medical Center
Frequently Asked Questions
Who can join the NCT06734026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury (TBI) Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06734026 currently recruiting?
Yes, NCT06734026 is actively recruiting participants. Contact the research team at khansen1@metrohealth.org for enrollment information.
Where is the NCT06734026 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06734026 clinical trial?
NCT06734026 is sponsored by MetroHealth Medical Center. The principal investigator is James Sulzer, PhD at MetroHealth Medical Center. The trial plans to enroll 20 participants.