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Successful Treatment of Recalcitrant Restless Legs Syndrome With ...

Successful Treatment of Recalcitrant Restless Legs Syndrome With ...

Successful Treatment of Recalcitrant Restless Legs Syndrome With

Successful Treatment of Recalcitrant Restless Legs Syndrome With Botulinum Toxin Type-A The diurnal urge to move, characteristic of restless legs syndrome (RLS), is often associated with uncomfortable sensations. In 1 series, up to 56% of patients had pain or uncomfortable sensations. 1 Just as the movements can occur in the back and arms, so can the discomfort of RLS occur in the same anatomic areas. Numerous pharmacologic modalities exist for the treatment of RLS. Oral medications can cause intolerable untoward effects and may have significant interactions. Unfortunately, RLS can remain refractory to treatment or even worsen with long-term use of certain agents. Botulinum toxins mediate pain relief by reducing peripheral sensitization and subsequently, though indirectly, by reducing central nervous system sensitization. Botulinum toxin type A (BTX- A) has been successfully applied to a variety of painful conditions and movement disorders. We report the effective use of BTX-A for the treatment of recalcitrant RLS in 3 adult patients. Joshua S. Rotenberg, M.D., M.M.S. 1 ; Kevin Cannard, M.D. 2 ; Marc DiFazio, M.D. 3 1 Wilford Hall USAF Medical Center, San Antonio, TX; 2 Walter Reed Army Medical Center, Washington, DC; 3 Capital Neurology, Olney, MD Study Objective: We report the effective use of injected BTX-A to treat refractory restless legs syndrome (RLS). Methods: This is an observational case series of 3 patients meeting the essential diagnostic criteria for RLS whose symptoms were refractory to or who refused oral medication. Areas of maximal discomfort were injected as described below. Results: Patient #1, a 58-year-old man with refractory RLS, received injections in both legs. The effect persisted for 12 weeks after injections. He temporarily stopped taking gabapentin. He experienced a mild increase in a timed run. Patient #2, a 38-year-old man with refractory RLS, received BTX-A injections in both legs and his lumbar paraspinal muscles. Three days after injection, he reported great improvement. Within 1 month, his Epworth Sleepiness Scale score had decreased from 19 to 5. He stopped oral therapy during the peak therapeutic period. There were no untoward effects. Patient #3, a 38-year-old woman had a prolonged Disclosure Statement This was not an industry supported study. Dr. DiFazio has participated in speaking engagements supported by Alleyum, Inc. Drs. Rotenberg and Cannard have indicated no financial conflicts of interest. Submitted for publication October 31, 2005 Accepted for publication January 9, 2006 Address correspondence to: Dr. Joshua Rotenberg, Neurology & Sleep Specialists, 525 Oak Centre, Suite 400, San Antonio, TX 78258; Tel: (210) 429- 5020; Fax (210) 490-5024 SCIENTIFIC INVESTIGATIONS Journal of Clinical Sleep Medicine, Vol. 2, No. 3, 2006 275 sleep latency due to RLS. BTX-A was administered in the legs. In 2 days, her discomfort and her subjective sleep latency improved. Both the urge to move and nocturnal restlessness resolved for 10 weeks. There were no untoward effects in all patients, and the response was repeated in successive injection cycles. Conclusions: Intramuscular BTX-A alleviated symptoms, reduced medication use, and/or reduced daytime sleepiness with minimal, if any, untoward effects. BTX-A should be further investigated in controlled studies as a treatment of RLS. Keywords: Restless legs syndrome, botulinum toxins, movement disorders, pain, chemodenervation Citation: Rotenberg JS; Cannard K; DiFazio M. Successful treatment of recalcitrant restless legs syndrome with botulinum toxin type-A. J Clin Sleep Med 2006;2(3):275-278. METHODS This is an observational case series. Between 2002 and 2004, we identified 3 individuals meeting the 4 essential diagnostic criteria for RLS who either were refractory to conventional treatment or who refused oral medication. These individuals had normal neurologic examinations. Informed consent was acquired for this off-label use of BTX-A. Areas of maximal discomfort were identified by the patients and injected with BTX-A as described below. Response was assessed clinically by the Epworth Sleepiness Scale (ESS) or by medication use. Case 1 Commentary Follows on Pages 279-280 A 52-year-old man presented with a long-standing history of RLS refractory to numerous medications, excessive daytime somnolence, and disturbed sleep. At 28 years of age, the patient had noted nocturnal leg spasms with secondary daytime fatigue. A polysomnogram demonstrated periodic limb movements of sleep. The patient was treated with diazepam, which improved sleep quality and decreased daytime fatigue but had no effect on the nocturnal leg movements. Several years later, he developed further sensory symptoms of RLS, described as a “very bothersome” urge to move his legs secondary to “deep and achy” sensations. Stretching or movement partially alleviated the symptoms that were worsened by sitting or lying down. Initially, these sensations occurred only

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