Clinical trial for Traumatic Brain Injury
Official title Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
ClinicalTrials.gov ID: NCT05048966
What this study is testing
- What it's testing
- Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For individuals with moderate/severe TBI:
- age 18-70
- at least 4 months post injury
- can read and speak English fluently
- has a support person who is willing to participate in the study
You likely can't join if
- has had a prior stroke or neurological disease other than TBI
- has unstable or uncontrolled seizures
- has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
- current alcohol and/or drug use that interferes with ability to carry out common everyday functions For individuals with chronic mild TBI: Inclusion...
- age 18-70
- at least 3 months post-injury
See the full eligibility criteria
- For individuals with moderate/severe TBI:
- age 18-70
- at least 4 months post injury
- can read and speak English fluently
- has a support person who is willing to participate in the study
- has had a prior stroke or neurological disease other than TBI
- has unstable or uncontrolled seizures
- has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
- current alcohol and/or drug use that interferes with ability to carry out common everyday functions For individuals with chronic mild TBI: Inclusion Criteria:
- age 18-70
- at least 3 months post-injury
- can read and speak English fluently
- has a support person who is willing to participate in the study Exclusion Criteria:
- has had a prior stroke or neurological disease other than mild TBI
- has unstable or uncontrolled seizures
- has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
- current alcohol and/or drug use that interferes with ability to carry out common everyday functions For Individuals with Alzheimer's Disease Related Dementias (ADRD) Inclusion Criteria:
- age 65 and older
- at least one-year post-diagnosis
- can read and speak English fluently
- has a support person who is willing to participate in this study Exclusion Criteria:
- has had a prior stroke or neurological disease other than ADRD
- has unstable or uncontrolled seizures
- has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
- current alcohol and/or drug use that interferes with ability to carry out common everyday functions For Support Persons: Inclusion Criteria:
- is the support person of an individual with moderate/severe TBI, chronic mild TBI or ADRD who is willing to participate in the study
- can read and speak English fluently Exclusion Criteria:
- has a significant neurological history (e.g. stroke or multiple sclerosis)
- has unstable or uncontrolled seizures
- has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
- current alcohol and/or drug use that interferes with ability to carry out common everyday functions
The study team makes the final eligibility decision.
Where it's taking place
- East Hanover, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include East Hanover, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.