Multiple Sclerosis Clinical Trial
Official title:
Spinal Direct Current Stimulation Effects on Pain in Multiple Sclerosis: Clinical and Neurophysiological Assessment and Evaluation of Endocannabinoid System Activity
Pain represents one of the most common symptoms of Multiple Sclerosis (MS) that can
seriously affect patient health-related quality of life.
Central neuropathic pain, the main form of pain in MS patients, represents a significant
clinical problem, in consideration of its poorly responsiveness to available therapies.
Direct Current Stimulation (tDCS) is a non-invasive, well-tolerated procedure with an high
and well documented neuromodulation activity at Central Nervous System (CNS) level. First
evidences obtained by animal, neurophysiological and clinical studies suggested its
potential efficacy in neuropathic pain treatment.
In particular spinal DCS (sDCS) has been proven to modulate Nociceptive Withdrawal Reflex
(NWR), an objective and sensitive tool to explore pain processing at the Spinal Level and
recommended by European Federation of Neurological Society (EFNS) to evaluate the analgesic
effect of treatments. In this order of view the investigators' objective is to investigate
sDCS efficacy in MS neurophatic pain treatment applying validated clinical scales,
neurophysiological acquisitions and specific biological marker dosages.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Relapsing-remitting (RR), secondary-progressive (SP) and primary-progressive (PP) MS patients, affected by neuropathic or nociceptive chronic pain conditions in accordance to 1994 IASP (International Association for the Study of Pain) classification Exclusion Criteria: - Any form of headache - Cognitive impairment (Minimental State Examination <= 21) - Psychiatry diseases, in particular depression (Back Depression Inventory Scale >15) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino | Pavia |
Lead Sponsor | Collaborator |
---|---|
IRCCS National Neurological Institute "C. Mondino" Foundation |
Italy,
Cruccu G, Anand P, Attal N, Garcia-Larrea L, Haanpää M, Jørum E, Serra J, Jensen TS. EFNS guidelines on neuropathic pain assessment. Eur J Neurol. 2004 Mar;11(3):153-62. — View Citation
Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4. — View Citation
Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. — View Citation
Nitsche MA, Seeber A, Frommann K, Klein CC, Rochford C, Nitsche MS, Fricke K, Liebetanz D, Lang N, Antal A, Paulus W, Tergau F. Modulating parameters of excitability during and after transcranial direct current stimulation of the human motor cortex. J Physiol. 2005 Oct 1;568(Pt 1):291-303. Epub 2005 Jul 7. — View Citation
O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. A report of a Cochrane systematic review and meta-analysis. Eur J Phys Rehabil Med. 2011 Jun;47(2):309-26. Epub 2011 Apr 14. Review. — View Citation
O'Connor AB, Schwid SR, Herrmann DN, Markman JD, Dworkin RH. Pain associated with multiple sclerosis: systematic review and proposed classification. Pain. 2008 Jul;137(1):96-111. Epub 2007 Oct 24. Review. — View Citation
Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol. 2005 Dec;58(6):840-6. Review. — View Citation
Sandrini G, Serrao M, Rossi P, Romaniello A, Cruccu G, Willer JC. The lower limb flexion reflex in humans. Prog Neurobiol. 2005 Dec;77(6):353-95. Epub 2005 Dec 28. Review. — View Citation
Solaro C, Brichetto G, Amato MP, Cocco E, Colombo B, D'Aleo G, Gasperini C, Ghezzi A, Martinelli V, Milanese C, Patti F, Trojano M, Verdun E, Mancardi GL; PaIMS Study Group. The prevalence of pain in multiple sclerosis: a multicenter cross-sectional study. Neurology. 2004 Sep 14;63(5):919-21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sDCS efficacy in pain as determined by NPSI and NRS scale | Spinal DCS (sDCS) has been proven to modulate Nociceptive Withdrawal Reflex (NWR), an objective and sensitive tool to explore pain processing at the Spinal Level and recommended by European Federation of Neurological Society (EFNS) to evaluate the analgesic effect of treatments. | 30 days | No |
Secondary | Central endocannabinoid level as determined by Activity of Fatty Acid Amide Hydrolase (FAAH) in platelets | The endocannabinoid system is involved in descending central pain control and can be modulated by other neurostimulation techniques as transcutaneous electrical nerve stimulation. The investigators suppose that one of the major effect of sDCS is to modulate supraspinal central pain control through activation of endocannabinoid system inducing the analgesic effect. Alteration of endocannabinoid system activity is also involved in other pathological aspects of Multiple Sclerosis as spasms, spasticity and incontinence and to acute and chronic neurodegeneration (anti-oxidant activity and inhibition of glutamate release and signalling). Activity of Fatty Acid Amide Hydrolase (FAAH) in platelets will be quantify. | 30 days | No |
Secondary | Spasticity as determined by Ashworth Scale | As sDCS reduces NWR area and as it may modulate endocannabinoid system, the investigators could suppose other positive effects of this treatment in Multiple Sclerosis patients as reduction of painful spasms and spasticity. The investigators will evaluate the effect of sDCS on spasticity, if present, investigating its effect on validate ad hoc scales (Ashworth scale) and on neurophysiological acquisitions (H reflex). | 30 days | No |
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