West Orange, NJ. August 20, 2015. Kessler researchers found preliminary evidence for the effectiveness of ramelteon for the treatment of sleep disturbances after traumatic brain injury (TBI). The article, "Pilot study on the effect of ramelteon on sleep disturbance after traumatic brain injury," was epublished ahead of print in the Archives of Physical Medicine and Rehabilitation on May 28, 2015. Authors are Anthony Lequerica, PhD, and Nancy Chiaravalloti, PhD, of Kessler Foundation, Neil Jasey, MD, of Kessler Institute for Rehabilitation, and Jaclyn Portelli Tremont, MA, of Robert Wood Johnson Medical School, Rutgers University.
Sleep problems affect 30% to 77% of Individuals with brain injury, affecting recovery and their ability to participate in rehabilitation. Mood disorders, fatigue and poor occupational outcomes are more common among people with sleep difficulties post TBI. Medications commonly used in treating sleep disturbance, including antidepressants, antihistamines and benzodiazepines, often have side effects that impair cognition. Ramelteon is a melatonin-agonist without the risks for dependence or addiction. Although it is approved for long-term treatment of insomnia, ramelteon had not been studied in this population.
Eighteen people with TBI were enrolled in this double-blind, placebo-controlled crossover trial. They completed five visits over nine weeks; evaluations included the neuropsychological testing, sleep variables, and mood measures. Participants were monitored using Actigraph, an electronic device worn on the wrist that measured the rest/activity cycle of the participants throughout the study, as well as by self report (sleep log). Outcomes measured included total sleep time (TST), sleep-onset latency (SOL) and cognitive functioning.
As in the non-TBI population, TST increased with three weeks of ramelteon 8 mg before bedtime, with maximal effectiveness achieved after one week of treatment. The TBI population responded differently in terms of SOL, taking a few minutes longer to fall asleep on ramelteon. While statistically significant, the increase was less than 5 minutes on average and not considered clinically significant. Cognition improved after 3 weeks of treatment, evidenced by improvement on the CNSVS Neurocognitive Index derived from a neuropsychological battery delivered via computer. A significant improvement was noted on the executive functioning subtest with marginally significant improvement in reaction time.
"Ramelteon increased the total time asleep and seemed to bring more order or consistency to the sleep-wake cycles. These preliminary findings indicate that ramelteon may be useful for treating sleep-wake disturbances among individuals with TBI," said Dr. Lequerica, clinical research scientist in TBI Research at Kessler Foundation. "It may be optimal to begin ramelteon during acute care," he noted. "By addressing sleep issues before rehabilitation starts, we can optimize the person's ability to engage in rehabilitative therapies."
This study was funded by the New Jersey Commission on Brain Injury Research (10-3222-BIR-E-0).
About TBI Research at Kessler Foundation
Nancy Chiaravalloti, PhD, is director of Neuroscience & TBI Research and project director of the Northern New Jersey TBI System (NNJTBIS), a collaborative effort of Kessler Foundation, Kessler Institute for Rehabilitation, and local hospitals. John DeLuca, PhD is co-project director. NNJTBIS is one of 16 federally funded model systems that form a national comprehensive system of care, research, education and dissemination aimed at improving quality of life for people with TBI. NNJTBIS is supported by grant #H133A120030 from the National Institute on Independent Living & Disability & Rehabilitation Research (NIDILRR). In addition to NIDRR and the Department of Defense, TBI research is funded by the New Jersey Commission on Brain Injury Research, the Department of Veterans Affairs, the Department of Defense, and Children's Specialized Hospital. Neuroimaging studies are conducted at the Rocco Ortenzio Neuroimaging Center at Kessler Foundation. Kessler researchers and clinicians have faculty appointments in the department of Physical Medicine and Rehabilitation at Rutgers New Jersey Medical School.
About Kessler Foundation
Kessler Foundation, a major nonprofit organization in the field of disability, is a global leader in rehabilitation research that seeks to improve cognition, mobility and long-term outcomes, including employment, for people with neurological disabilities caused by diseases and injuries of the brain and spinal cord. Kessler Foundation leads the nation in funding innovative programs that expand opportunities for employment for people with disabilities. For more information, visit KesslerFoundation.org.
Carolann Murphy, PA; 973.324.8382; cmurphy@KesslerFoundation.org
Lauren Scrivo, 973.324.8384/973.768.6583 (cell); LScrivo@KesslerFoundation.org
Archives of Physical Medicine and Rehabilitation