Amantadine + rTMS as a Neurotherapeutic for Disordered Consciousness

Status Completed

Clinical Trial Summary

The purpose of this study is to examine the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) combined with Amantadine relative to rTMS Alone and Amantadine Alone for persons in chronic states of seriously impaired consciousness. The hypothesis is that provision of rTMS+Amantadine will provide a safe yet synergistic effect that induces or accelerates functional recovery.

Clinical Trial Description

The R21 research objective is to examine the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) combined with Amantadine (TMS + Amantadine) relative to rTMS Alone and Amantadine Alone for persons in chronic states of seriously impaired consciousness. The hypothesis is that provision of rTMS+Amantadine will provide a safe yet synergistic effect that induces or accelerates functional recovery. This hypothesis is based on (a) preliminary data indicating partially improved neurobehavioral functioning mechanistically related to rTMS-induced neural activity and connectivity as well as improved integrity of white fiber tracts, (b) relationship between dopamine (DA) and common traumatic brain injury (TBI) impairments, (c) role of DA in mediating consciousness, (d) the commonality between and DA and rTMS-targeted pathways, (e) clinical efficacy and safety of Amantadine, (f) mechanisms of action of Amantadine, and (g) the association between rTMS and Amantadine with up-regulating brain derived neurotrophic factor. The rationale is that pairing rTMS with Amantadine will have a complementary and synergistic effect on factors promoting conscious behavior. The specific aims are to: (1) Demonstrate that rTMS+Amantadine is safely tolerated, (2) Determine neurobehavioral effect of rTMS+Amantadine, and (3) Characterize pre-and post-treatment neural changes in neural activation. Aim 1 is based on our preliminary safety data and safety data regarding Amantadine. To address Aims 2 & 3 we use a repeated measures baseline control design with randomized treatment orders yielding three treatment groups; rTMS + Amantadine, rTMS Alone and Amantadine Alone. Analyses for Aims 2 and 3 involve comparing these treatment groups according to neurobehavioral growth trajectories, mean amount of neural activation and connectivity within and between brain regions, and indices of fiber tract directionality. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02025439
Study type	Interventional
Source	Edward Hines Jr. VA Hospital
Contact
Status	Completed
Phase	N/A
Start date	February 2014
Completion date	July 2016

View Details

See also
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	`NCT04199130` - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI	N/A
Withdrawn	`NCT05062148` - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery	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