Disorder of Consciousness — Safety and Efficacy of tDCS in Pediatric DoC
Citation(s)
Chung MG, Lo WD Noninvasive brain stimulation: the potential for use in the rehabilitation of pediatric acquired brain injury. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S129-37. doi: 10.1016/j.apmr.2014.10.013. Epub 2014 Nov 6.
Elbanna ST, Elshennawy S, Ayad MN Noninvasive Brain Stimulation for Rehabilitation of Pediatric Motor Disorders Following Brain Injury: Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2019 Oct;100(10):1945-1963. doi: 10.1016/j.apmr.2019.04.009. Epub 2019 May 10.
Saleem GT, Ewen JB, Crasta JE, Slomine BS, Cantarero GL, Suskauer SJ Single-arm, open-label, dose escalation phase I study to evaluate the safety and feasibility of transcranial direct current stimulation with electroencephalography biomarkers in paediatric disorders of consciousness: a study protocol. BMJ Open. 2019 Aug 10;9(8):e029967. doi: 10.1136/bmjopen-2019-029967.
Safety and Efficacy of Transcranial Direct Current Stimulation in Pediatric Disorders of Consciousness
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
