Status:
COMPLETED
Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Brain Injury
Dementia Alzheimers
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Patients with a history of traumatic brain injury (TBI) are at elevated risk for Alzheimer's disease and related dementias (ADRD). Improvements in TBI treatment may mitigate this risk. Complex motor a...
Detailed Description
Patients with a history of traumatic brain injury (TBI) are at elevated risk for Alzheimer's disease and related dementias (ADRD). Improvements in TBI treatment may mitigate this risk. The treatment o...
Eligibility Criteria
Inclusion
- English speaking
- 40 years of age and older
- History of at least one remote TBI (\>3 years ago) of mild and moderate severity as diagnosed by Veteran's Affairs / Department of Defense (VA/DoD) criteria.
- Ability to perform most independent activities of daily living without physical assistance (e.g., no canes or walkers because person needs both hands to participate); Chedoke Arm and Hand Activity Inventory - mean score \>5, indicating modified or complete independence in hand and arm functioning.
- Ability to dedicate 3 hours per week for about 12 weeks-approximately 20 to 26 hours of total time-to the intervention study.
- Ability to give informed consent and understand the tasks involved
Exclusion
- Presence of cognitive impairment based on a Mini-Mental State Exam (MMSE) score ≤ 24.
- Presence of diseases associated with gross motor abnormalities that restrict ambulation (e.g., stroke with paresis, multiple sclerosis, amyotrophic lateral sclerosis, cerebellar or spinal cord disorders, peripheral nerve disorders, severe rheumatic or osteoarthritic disorders, limb amputation)
- Untreated major mental illness that may preclude successful completion of the study (e.g., major depressive disorder, anxiety disorders, etc.)
- History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g., epilepsy, severe arthritis, severe neuropathy, Parkinson's disease).
- Current diagnosis of color blindness.
- Social or personal circumstances that interfere with ability to complete 12-14 weeks of training sessions and follow-up evaluation.
- Inability to sit in a chair or stand and perform upper limb exercises for one hour at a time.
Key Trial Info
Start Date :
January 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04073225
Start Date
January 25 2020
End Date
September 3 2024
Last Update
October 7 2025
Active Locations (1)
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1
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224