A Phase 1/2,Open-Label Study to Evaluate the Safety and Efficacy of the International Brain Research Foundation (IBRF) Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Patients With Severe Disorders of Consciousness

NCT02696512 Phase 1/Phase 2 UNKNOWN

This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention protocol in patients with severe disorders of consciousness (SDOC).

Details

Lead sponsor	International Brain Research Foundation
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	30
Start date	2016-03
Completion	2017-04

Conditions

• Brain Injury

Interventions

• Polypharmacy using FDA-approved products
• Median Nerve Stimulation (MNS)
• Nutraceutical Supplementation
• Standard of Care

Primary outcomes

• Tolerance to treatment — Week 12
  The percent of patients completing the treatment protocol
• Number and Frequency of side effects — Week 12
  The total number and frequency of side effects experienced by patients based on observations and evaluations of the patients' clinical laboratory tests
• Adverse events — Week 12
  Based on observations of the study patients and evaluations of clinical laboratory tests

Countries

United States