NCT02331654

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

December 16, 2014

Last Update Submit

January 5, 2015

Conditions

Multiple Sclerosis

Keywords

Chronic painDirect Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Central endocannabinoid level as determined by Activity of Fatty Acid Amide Hydrolase (FAAH) in platelets

    30 days

  • Spasticity as determined by Ashworth Scale

    30 days

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

Placebo treatment

PLACEBO COMPARATOR

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

Interventions

Experimental treatmentOTHER

Anodal DC stimulation (2 mA, 20 min) will be delivered by a constant direct current electrical stimulator connected to a pair of electrodes

Experimental Treatment
Placebo treatmentOTHER

Electrodes will be placed as for active stimulation, but the stimulator will automatically turn off after 10 s

Placebo treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any form of headache
  • Cognitive impairment (Minimental State Examination \<= 21)
  • Psychiatry diseases, in particular depression (Back Depression Inventory Scale \>15)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino

Pavia, Pavia, 27100, Italy

RECRUITING

Related Publications (10)

  • 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. doi: 10.1212/01.wnl.0000137047.85868.d6.

    PMID: 15365151BACKGROUND

  • 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. doi: 10.1016/j.pain.2007.08.024. Epub 2007 Oct 24.

    PMID: 17928147BACKGROUND

  • 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. doi: 10.1113/jphysiol.2005.092429. Epub 2005 Jul 7.

    PMID: 16002441BACKGROUND

  • 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.

    PMID: 18525028BACKGROUND

  • 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. doi: 10.1111/j.1528-1167.2006.00426.x.

    PMID: 16499758BACKGROUND

  • 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.

    PMID: 21494222BACKGROUND

  • 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. doi: 10.1002/ana.20703.

    PMID: 16283615BACKGROUND

  • Cruccu G, Anand P, Attal N, Garcia-Larrea L, Haanpaa M, Jorum E, Serra J, Jensen TS. EFNS guidelines on neuropathic pain assessment. Eur J Neurol. 2004 Mar;11(3):153-62. doi: 10.1111/j.1468-1331.2004.00791.x.

    PMID: 15009162BACKGROUND

  • 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. doi: 10.1016/j.pneurobio.2005.11.003. Epub 2005 Dec 28.

    PMID: 16386347BACKGROUND

  • Berra E, Bergamaschi R, De Icco R, Dagna C, Perrotta A, Rovaris M, Grasso MG, Anastasio MG, Pinardi G, Martello F, Tamburin S, Sandrini G, Tassorelli C. The Effects of Transcutaneous Spinal Direct Current Stimulation on Neuropathic Pain in Multiple Sclerosis: Clinical and Neurophysiological Assessment. Front Hum Neurosci. 2019 Feb 12;13:31. doi: 10.3389/fnhum.2019.00031. eCollection 2019.

    PMID: 30809137DERIVED

MeSH Terms

Conditions

Multiple SclerosisChronic Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giorgio Sandrini, MD

    IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Fattore, MD

CONTACT

+39 0382 380818cinzia.fattore@mondino.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 6, 2015

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Study Completion

February 1, 2016

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

IT(1)