Traumatic Brain Injury Clinical Trial
Official title:
Randomized Controlled Trial of Galantamine, Methylphenidate, and Placebo for the Treatment of Cognitive Symptoms in Patients With Traumatic Brain Injury (TBI) and/or Posttraumatic Stress Disorder (PTSD)
This study will evaluate the efficacy of methylphenidate and galantamine in the treatment of persistent cognitive symptoms associated with posttraumatic stress disorder (PTSD) and/or traumatic brain injury (TBI).
Both traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) are prevalent in
service members returning from Operation Enduring Freedom, Operation Iraqi Freedom, and
Operation New Dawn (OEF/OIF/OND). Virtually all individuals who suffer TBI (TBI) have acute
cognitive effects, and a significant number have persistent symptoms. A large number of
individuals with PTSD also report problems with cognition, however, little is known about
the treatment of cognitive complaints in either condition and less is known about cognitive
complaints in individuals with co-occurring TBI and PTSD.
There is some preclinical evidence that both the cholinergic and catecholaminergic
neurotransmitter systems play important roles in cognitive function in healthy individuals
as well as those with mTBI and/or PTSD. We propose to evaluate the efficacy of two
pharmacotherapies, one that predominantly augments cholinergic function (galantamine [GAL])
and one that augments predominantly catecholaminergic function (methylphenidate [MPH]), for
reducing cognitive symptoms in individuals with TBI and/or PTSD.
Using a double-blind, randomized, placebo controlled design, 159 individuals with TBI and/or
PTSD with persistent cognitive complaints will be randomized to receive galantamine 12 mg
BID, methylphenidate 20 mg BID, or placebo for 12 weeks. The primary objective is to assess
the efficacy of galantamine and methylphenidate in reducing cognitive complaints in patients
with PTSD and/or TBI. Secondary objectives are to assess the extent to which non-cognitive
distress responds to galantamine or methylphenidate, and assess the effect that galantamine
and methylphenidate have on cognitive performance.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
| Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
| Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
| Terminated |
NCT03698747 -
Myelin Imaging in Concussed High School Football Players
|
||
| Recruiting |
NCT05130658 -
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
|
N/A | |
| Recruiting |
NCT04560946 -
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
|
N/A | |
| Completed |
NCT05160194 -
Gaining Real-Life Skills Over the Web
|
N/A | |
| Recruiting |
NCT02059941 -
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
|
N/A | |
| Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
| Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
| Completed |
NCT04465019 -
Exoskeleton Rehabilitation on TBI
|
||
| Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
| Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
| Suspended |
NCT04244058 -
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
|
Early Phase 1 | |
| Completed |
NCT03307070 -
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
|
N/A | |
| Recruiting |
NCT04274777 -
The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
|
||
| Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
| Withdrawn |
NCT04199130 -
Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
|
N/A | |
| Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 |