Amantadine + rTMS as a Neurotherapeutic for Disordered Consciousness

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edward Hines Jr. VA Hospital
• Treatments: Amantadine

Criteria

Inclusion Criteria:

• 18-64 years of age

• Suffered a severe brain injury of traumatic origin at least 1-year prior to study enrollment

• Remain in a state of disordered consciousness

• Brain injuries will include injury with resulting coup-contre-coup injuries, excluding persons with trauma due to blunt injuries and/or non-traumatic encephalopathy

Exclusion Criteria:

• Have 1 or more Amantadine contraindications: On monoamino oxidase inhibitor-B, hypersensitivity/idiosyncrasy to sympathomimetic amines, uncontrolled hypertension, glaucoma or Congestive Heart Failure

• Have contraindications to Amantadine Dose of 200 mg Daily as determined by estimated Glomerular Filtration Rate (eGFR) ≤ 60 (ml/min)

• Abnormal results of Liver Function Test at screening

• Receiving anti-epileptic medications to control active seizures or have had a documented seizure within three months of study enrollment

• Incurred large cortically based ischemic infarction/encephalomalacia subsequent to TBI

• Have documented history of previous TBI, psychiatric illness (DSM criteria) and/or organic brain syndrome such as Alzheimer's

• Are using medications which may interfere with Amantadine and cannot be safely titrated or discontinued

• Are pregnant

• Have implanted cardiac pacemaker or defibrillator, cochlear implant, nerve stimulator, intracranial metal clips

• Have MRI and/or TMS contraindications such as: History of claustrophobia, metal in eyes/face, shrapnel/bullet remnants in brain

• Are fully conscious as indicated by a score of 6 on the Motor Function scale and/or a score of 2 on the Communication scale of the CRS-R,

• Are within first year of injury

• Are <18 years of age and > 65 years of age

• Have an injury or condition due to blunt trauma only or non-traumatic encephalopathy

• Have programmable CSF shunt or are ventilator dependent