Traumatic Brain Injury Clinical Trial
Official title:
Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury
NCT number | NCT03817086 |
Other study ID # | R970-17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 28, 2017 |
Est. completion date | June 30, 2021 |
Verified date | October 2022 |
Source | Kessler Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Traumatic Brain Injury (TBI)patients often suffer from loss of muscle strength in the hand and foot, decrease in coordination and high muscle tone (spasticity). In this study, investigators seek to compare how two different training programs can improve the coordination and symptoms of fatigue in individuals with movement deficits secondary to TBI. Using brain imaging, the study will also investigate changes in brain structure and activity associated with hand movement.
Status | Completed |
Enrollment | 19 |
Est. completion date | June 30, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: - between the ages of 20 to 60 years old. - have been diagnosed with a moderate to severe Traumatic Brain Injury. - must have had the injury more than 12 months ago. - have problems controlling my arm movements. - right handed. - speak and understand English. - willing and able to travel to Kessler Foundation in West Orange, NJ for the 3 testing sessions and the 12 sessions of intervention. - must have stable health with no expected medication changes for the next 4 months. - able to understand instructions that are part of the testing and intervention. Exclusion Criteria: - have had a penetrating Traumatic Brain Injury. - have severe spasticity (stiffness and tightness in my muscles) as determined by study staff. - have had other brain injuries or illnesses in addition to the Traumatic Brain Injury (for example, epilepsy, MS). - use illegal substances at this time, like drugs - have had a brain injury that was non-traumatic such as a stroke or brain tumor. - am enrolled in another research study that is likely to affect my participation in this research study. - have a history of psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis). |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Maximum voluntary contraction | maximum force exerted by each hand during squeezing a handgrip force sensor | Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training) | |
Primary | Change in Reaction Time | Reaction time is the time between real movement, and the time participant was instructed to move. This reaction time will be recorded for every training trial. The average of reaction time in each training day (total 12) will be used to examine the change in performance (slope) across the 12 training days, from day 1 until day 12 of the intervention. | day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12 | |
Primary | Change in Percent of Error in force matching | Percent of error is the mismatch between the force exerted by the participant and the required force as per the instructions in each training trial. This Percent of Error will be recorded for every training trial. The average of errors in each training day (total 12) will be used to examine the change (slope) in performance across the 12 sessions (days) of the intervention. | day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12 | |
Primary | Change in wolf motor function test | assessment of upper extremity function | Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training) | |
Primary | Change in within-brain effective connectivity | connectivity between sensorimotor and attention network during inphase and out-phase hand coordination task | Pretest (before training), Posttest (immediately after end of training) | |
Primary | Change in resting state function connectivity | connectivity between sensorimotor and attention network at rest | Pretest (before training), Posttest (immediately after end of training) | |
Primary | Change in brain structural connectivity (DTI) | cerebrospinal tract connectivity | Pretest (before training), Posttest (immediately after end of training) | |
Secondary | stroop effect test | neuropsychology assessments of reaction time | Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training) | |
Secondary | trail making test | neuropsychology assessments of task switching and visual attention | Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training) |
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