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Spinal Direct Current Stimulation Effects on Pain in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02331654
Recruitment Status : Unknown
Verified January 2015 by IRCCS National Neurological Institute "C. Mondino" Foundation.
Recruitment status was:  Recruiting
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Experimental treatment Other: Placebo treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Spinal Direct Current Stimulation Effects on Pain in Multiple Sclerosis: Clinical and Neurophysiological Assessment and Evaluation of Endocannabinoid System Activity
Study Start Date : November 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: Experimental Treatment
Anodal DC stimulation (2 mA, 20 min) will be delivered by a constant direct current electrical stimulator connected to a pair of electrodes: the anode will be placed on the thoracic spinal cord (over the spinal process of the tenth thoracic vertebra) and the cathode (reference) above the right shoulder. Stimulating electrodes will be thick (6 mm), rectangular pieces of saline-soaked synthetic sponge. The sDCS polarity (anodal) will refer to the electrode over the spinal cord.
Other: Experimental treatment
Anodal DC stimulation (2 mA, 20 min) will be delivered by a constant direct current electrical stimulator connected to a pair of electrodes

Placebo Comparator: Placebo treatment
For sham sDCS (placebo), electrodes will be placed as for active stimulation, but the stimulator will automatically turn off after 10 s.
Other: Placebo treatment
Electrodes will be placed as for active stimulation, but the stimulator will automatically turn off after 10 s




Primary Outcome Measures :
  1. sDCS efficacy in pain as determined by NPSI and NRS scale [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Central endocannabinoid level as determined by Activity of Fatty Acid Amide Hydrolase (FAAH) in platelets [ Time Frame: 30 days ]
    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.

  2. Spasticity as determined by Ashworth Scale [ Time Frame: 30 days ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331654


Contacts
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Contact: Cinzia Fattore, MD +39 0382 380818 cinzia.fattore@mondino.it

Locations
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Italy
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino Recruiting
Pavia, Italy, 27100
Contact: Giorgio Sandrini, MD    +39 0382 380435    giorgio.sandrini@unipv.it   
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
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Principal Investigator: Giorgio Sandrini, MD IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT02331654    
Other Study ID Numbers: 2786/13
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
Chronic pain
Direct Current Stimulation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases