Brown KJ, Jewells V, Herfarth H, Castillo M White matter lesions suggestive of amyotrophic lateral sclerosis attributed to celiac disease. AJNR Am J Neuroradiol. 2010 May;31(5):880-1. doi: 10.3174/ajnr.A1826. Epub 2009 Nov 12.
Coyne N, Correnti D Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? Home Healthc Nurse. 2014 Jan;32(1):56-63. doi: 10.1097/NHH.0000000000000001. Review.
Inam S, Vucic S, Brodaty NE, Zoing MC, Kiernan MC The 10-metre gait speed as a functional biomarker in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2010 Dec;11(6):558-61. doi: 10.3109/17482961003792958. Epub 2010 Jun 2.
Irish AK, Erickson CM, Wahls TL, Snetselaar LG, Darling WG Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2017 Jan 4;7:1-18. doi: 10.2147/DNND.S116949. eCollection 2017.
Jin Y, Oh K, Oh SI, Baek H, Kim SH, Park Y Dietary intake of fruits and beta-carotene is negatively associated with amyotrophic lateral sclerosis risk in Koreans: a case-control study. Nutr Neurosci. 2014 Apr;17(3):104-8. doi: 10.1179/1476830513Y.0000000071. Epub 2013 Nov 26.
Lee JE, Bisht B, Hall MJ, Rubenstein LM, Louison R, Klein DT, Wahls TL A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis. J Am Coll Nutr. 2017 Mar-Apr;36(3):150-168. doi: 10.1080/07315724.2016.1255160. Epub 2017 Apr 10.
Martin JL, Hakim AD Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872. Review.
Milonas I Amyotrophic lateral sclerosis: an introduction. J Neurol. 1998 Aug;245 Suppl 2:S1-3.
Ngo ST, Steyn FJ, McCombe PA Body mass index and dietary intervention: implications for prognosis of amyotrophic lateral sclerosis. J Neurol Sci. 2014 May 15;340(1-2):5-12. doi: 10.1016/j.jns.2014.02.035. Epub 2014 Mar 3. Review.
Park Y, Park J, Kim Y, Baek H, Kim SH Association between nutritional status and disease severity using the amyotrophic lateral sclerosis (ALS) functional rating scale in ALS patients. Nutrition. 2015 Nov-Dec;31(11-12):1362-7. doi: 10.1016/j.nut.2015.05.025. Epub 2015 Jul 6.
Rao TV, Tharakan JK, Jacob PC Systemic lupus erythematosus presenting as amyotrophic lateral sclerosis. Clin Neuropathol. 2004 May-Jun;23(3):99-101.
Roubeau V, Blasco H, Maillot F, Corcia P, Praline J Nutritional assessment of amyotrophic lateral sclerosis in routine practice: value of weighing and bioelectrical impedance analysis. Muscle Nerve. 2015 Apr;51(4):479-84. doi: 10.1002/mus.24419. Epub 2015 Feb 24.
Salvioni CC, Stanich P, Almeida CS, Oliveira AS Nutritional care in motor neurone disease/ amyotrophic lateral sclerosis. Arq Neuropsiquiatr. 2014 Feb;72(2):157-63. doi: 10.1590/0004-282X20130185. Review.
Vansteenkiste M, Williams GC, Resnicow K Toward systematic integration between self-determination theory and motivational interviewing as examples of top-down and bottom-up intervention development: autonomy or volition as a fundamental theoretical principle. Int J Behav Nutr Phys Act. 2012 Mar 2;9:23. doi: 10.1186/1479-5868-9-23.
Wang MD, Little J, Gomes J, Cashman NR, Krewski D Identification of risk factors associated with onset and progression of amyotrophic lateral sclerosis using systematic review and meta-analysis. Neurotoxicology. 2017 Jul;61:101-130. doi: 10.1016/j.neuro.2016.06.015. Epub 2016 Jul 1. Review.
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.