20 Participants Needed

Cafe Therapy for Traumatic Brain Injury

KH
TN
Overseen ByTom Nown
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: MetroHealth Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Cafe Therapy for individuals with moderate to severe traumatic brain injury. The therapy occurs in a café setting, where participants perform tasks like serving drinks and snacks to determine if this environment aids recovery more effectively than regular therapy. Participants will work in the café with guidance for a few hours each week over two months. The study seeks individuals who have lived with a brain injury for over three months, have physical challenges, and can stand with support for two hours. Participants should be able to follow instructions and have been discharged from formal therapy programs. As an unphased trial, this study offers a unique opportunity to explore innovative recovery methods in a supportive environment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this therapy is safe for participants with traumatic brain injury?

Research has shown that Cafe Therapy, which involves working in a cafe-like setting, may benefit people with traumatic brain injuries. In past studies, environments like the Metro Café, which combine different therapies, have been used safely. These studies found that such settings can be part of regular care without major problems. Participants often reported feeling less tired and more aware of their fatigue, suggesting the approach is well-tolerated.

Although this trial does not involve testing a drug, caffeine, often found in cafes, has shown potential benefits in studies. For instance, certain levels of caffeine in the blood have been linked to better recovery for people with brain injuries.

Overall, performing simple cafe tasks, like serving drinks, in a supportive environment may aid recovery without causing harm. Since this is a new approach, safety evidence is still being collected. However, the trial's design suggests it is considered safe enough to test with people.12345

Why are researchers excited about this trial?

Cafe Therapy is unique because it uses a social and occupational approach to aid recovery from traumatic brain injury (TBI). Unlike standard medical treatments, which often involve medications and physical therapy, Cafe Therapy involves participants working as volunteer cafe employees, providing a real-world setting for cognitive and social rehabilitation. Researchers are excited about this method because it offers a more holistic approach, potentially enhancing social skills and fostering a sense of purpose and routine in daily life. This innovative approach could open up new avenues for non-pharmaceutical interventions in TBI recovery.

What evidence suggests that Cafe Therapy is effective for traumatic brain injury?

Research has shown that environments with various therapies can aid recovery in individuals with long-term traumatic brain injuries (TBI). In this trial, participants in the Cafe Therapy arm will engage in activities such as serving drinks and snacks in a café setting to foster such an environment. Studies have found that combining multiple types of therapy can enhance recovery more effectively than traditional therapy alone. Evidence suggests that ongoing treatments, including those using caffeine, can reduce brain damage and swelling in TBI cases. Although direct data on Cafe Therapy is limited, it is based on proven methods that support recovery after a brain injury.13567

Who Is on the Research Team?

JS

James Sulzer, PhD

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with chronic traumatic brain injury who are seeking to improve their recovery outcomes. Participants will engage in a unique 'Cafe Therapy' during the study, which involves serving customers and performing tasks in a simulated cafe environment.

Inclusion Criteria

I have been discharged from my recent therapy.
Ability to comprehend multi-step instructions
I can stand up with some support.
See 7 more

Exclusion Criteria

Medical instability
Prisoners
Pregnant women
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in Metro Café therapy sessions, performing tasks such as serving customers and maintaining supplies, 3 times per week for 2 months

8 weeks
18 visits (in-person)

Control

Participants in the control group do not receive any intervention during the 2 months between assessments

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including functional assessments and surveys

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cafe Therapy
Trial Overview The study tests if an enriched environment called Metro Café, offering multi-modal therapy (combining speech, cognition, and physical movement therapies), leads to better recovery than traditional methods. It measures therapy dosage and its correlation with clinical outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cafe TherapyExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials
125
Recruited
22,600+

Citations

Cafe Therapy for Traumatic Brain InjuryThis trial is for individuals with chronic traumatic brain injury who are seeking to improve their recovery outcomes. Participants will engage in a unique 'Cafe ...
Caffeine: A Neuroprotectant and Neurotoxin in Traumatic ...The dose–response results after diffuse injury show that a 25 mg/kg caffeine treatment in rats significantly reduces acute mortality by 75% without impairing ...
Full article: A virtual rehabilitation tool for cognitive ...Results. The tool was successfully integrated into usual clinical care. TBI participants showed a trend of reduced fatigue and increased awareness of fatigue.
Multimodal, Enriched Environment for Rehabilitation in ...... traumatic brain injury improves outcomes of recovery better than traditional therapy. ... Behavioral: Cafe Therapy Participants will be ...
Chronic but not acute treatment with caffeine attenuates ...We demonstrated that chronic treatment with caffeine attenuates TBI-induced neurological deficit and cerebral edema in mice.
Multimodal, Enriched Environment for Rehabilitation in ...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 ...
Serum Caffeine Concentration at the Time of Traumatic ...This study showed a significant association between a serum caffeine concentration of 0.01 to 1.66 μg/mL and good functional recovery at 6 months after injury ...
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