Multiple SclerosisNCT02331654
Spinal Direct Current Stimulation Effects on Pain in Multiple Sclerosis
A study testing Experimental treatment in people with Multiple Sclerosis, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Experimental treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any form of headache
- Cognitive impairment (Minimental State Examination <= 21)
- Psychiatry diseases, in particular depression (Back Depression Inventory Scale >15)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia, Pavia, 27100
Giorgio Sandrini, MD, +39 0382 380435, giorgio.sandrini@unipv.it
About this study
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.
Read more
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.
Read the detailed description
The investigators plan to recruit, at the IRCCS Neurological National Institute C. Mondino, 60 consecutive patients with definite Multiple Sclerosis (MS) according to 2005 McDonald criteria in a follow-up procedure that includes a general and neurological evaluation scored according to the Expanded Disability Status Scale of Kurtzke and its functional systems.
Relapsing-remitting (RR), secondary-progressive (SP) and primary-progressive (PP) MS patients, affecting by neuropathic or nociceptive chronic pain conditions in accord to 1994 International Association for the Study of Pain (IASP)classification, will be recruited. Patients complaining any form of headache will be excluded by the study. The investigators will excluded also patients with cognitive impairment (Minimental State Examination - MMSE- <= 21) and psychiatry diseases, in particular depression (Back Depression Inventory Scale - BDI - >15).
Characteristic and intensity of pain symptoms will be collected respectively with validated Italian version of Neuropathic Pain Symptoms Inventory Scale (NPSI) and Numerical Rating Scale (NRS). Spasticity of lower legs, if present, will be clinical assessed with Ashworth Scale and Neurophysiologically evaluated with H/M ratio and Vibratory Inhibition of H-Reflex.
Health-Related Quality of Life (HRQoL) will be assessed by means of the Medical Outcome 36-item Short Form Health Survey (SF-36) whereas the presence and severity of fatigue will be assessed by means of the Fatigue Severity Scale (FSS).
RR patients will be evaluated in stationary phase of the disease that is at least two months after the last clinical relapse and at least one month after the end of a steroidal treatment.
Patients will be consecutive enrolled in the study and randomly assigned to two group: 1. Sham and 2. Anodal Spinal Direct Current Stimulation Treatment, in a double-blind, placebo controlled study design.
Before enrollment, the study protocol will be explained to each subject, and informed written consent will be obtained.
The investigators will proceed as follow:
- Time of enrollment - T0 First Day
- Complete clinical evaluation with administration of MMSE and BDI for exclusion criteria
- Randomized assignment to Anodal or Sham treatment group
- Administration of NPSI, SF-36, HRQoL e FSS
- Evaluation of Somatosensory Evoked Potential by Posterior Tibial and Medial Nerve stimulation to investigate the somatosensory pathway involvement.
- Clinical and Neurophysiological evaluation of Spasticity (if present): Ashworth Scale and H/M ratio and HReflex Vibratory Inhibition.
- Collection of blood sample to evaluate activity of Fatty Acid Amide Hydrolase (FAAH) in platelets. Second Day
- First Anodal or Sham Direct Current Stimulation Treatment Session (sDCS)
- Neurophysiological acquisition of Nociceptive Withdrawal Reflex (NWR) and NWR Temporal Summation (see 'Neurophysiological Acquisition' Session for details) before and after 30 and 60 minutes the first sDCS treatment
- sDCS Treatment After evaluation at T0 patients will undergo 10 daily sDCS treatment, 5 days a week (see sDCS treatment session for details).
- Evaluation after 10 days of treatment - T1
- Administration of NPSI, SF-36, HRQoL e FESS
- Clinical and Neurophysiological evaluation of Spasticity (if present): Ashworth Scale and H/M ratio and HReflex Vibratory Inhibition.
- Collection of blood sample to evaluate activity of Fatty Acid Amide Hydrolase (FAAH) in platelets.
- Neurophysiological acquisition of Nociceptive Withdrawal Reflex (NWR) and NWR Temporal Summation
- Evaluation after 1 month from the end of treatment - T2
- Administration of NPSI, SF-36, HRQoL e FESS
- Clinical and Neurophysiological evaluation of Spasticity (if present): Ashworth Scale and H/M ratio and HReflex Vibratory Inhibition.
- Collection of blood sample to evaluate activity of Fatty Acid Amide Hydrolase (FAAH) in platelets.
- Neurophysiological acquisition of Nociceptive Withdrawal Reflex (NWR) and NWR Temporal Summation
- Conditions
- Multiple Sclerosis
- Being tested
- Experimental treatment, Placebo treatment
- Keywords
- Chronic pain, Direct Current Stimulation
- Medical subject headings
- Multiple Sclerosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Placebo treatmentOther
Electrodes will be placed as for active stimulation, but the stimulator will automatically turn off after 10 s
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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.
Measured: 30 days
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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startNov 2013
- Primary completionJun 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Sandrini, MD, Principal investigator, IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331654
- Sponsor's protocol ID
- 2786/13
- Status last verified
- Jan 2015
- First submitted
- 16 Dec 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15365151O'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.
PubMed 17928147Nitsche 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.
PubMed 16002441Ferrucci 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.
PubMed 18525028Fregni 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.
PubMed 16499758O'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.
PubMed 21494222Polman 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.
PubMed 16283615Cruccu 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.
PubMed 15009162Sandrini 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.
PubMed 16386347Berra 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.
PubMed 30809137
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Direct Current Stimulation Effects on Pain in Multiple Sclerosis: Clinical and Neurophysiological Assessment and Evaluation of Endocannabinoid System Activity
- ClinicalTrials.gov ID
- NCT02331654
- Acronym / sponsor ID
- 2786/13
- Conditions
- Multiple Sclerosis
- Keywords
- Chronic pain, Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators plan to recruit, at the IRCCS Neurological National Institute C. Mondino, 60 consecutive patients with definite Multiple Sclerosis (MS) according to 2005 McDonald criteria in a follow-up procedure that includes a general and neurological evaluation scored according to the Expanded Disability Status Scale of Kurtzke and its functional systems.
Relapsing-remitting (RR), secondary-progressive (SP) and primary-progressive (PP) MS patients, affecting by neuropathic or nociceptive chronic pain conditions in accord to 1994 International Association for the Study of Pain (IASP)classification, will be recruited. Patients complaining any form of headache will be excluded by the study. The investigators will excluded also patients with cognitive impairment (Minimental State Examination - MMSE- <= 21) and psychiatry diseases, in particular depression (Back Depression Inventory Scale - BDI - >15).
Characteristic and intensity of pain symptoms will be collected respectively with validated Italian version of Neuropathic Pain Symptoms Inventory Scale (NPSI) and Numerical Rating Scale (NRS). Spasticity of lower legs, if present, will be clinical assessed with Ashworth Scale and Neurophysiologically evaluated with H/M ratio and Vibratory Inhibition of H-Reflex.
Health-Related Quality of Life (HRQoL) will be assessed by means of the Medical Outcome 36-item Short Form Health Survey (SF-36) whereas the presence and severity of fatigue will be assessed by means of the Fatigue Severity Scale (FSS).
RR patients will be evaluated in stationary phase of the disease that is at least two months after the last clinical relapse and at least one month after the end of a steroidal treatment.
Patients will be consecutive enrolled in the study and randomly assigned to two group: 1. Sham and 2. Anodal Spinal Direct Current Stimulation Treatment, in a double-blind, placebo controlled study design.
Before enrollment, the study protocol will be explained to each subject, and informed written consent will be obtained.
The investigators will proceed as follow:
- Time of enrollment - T0 First Day
- Complete clinical evaluation with administration of MMSE and BDI for exclusion criteria
- Randomized assignment to Anodal or Sham treatment group
- Administration of NPSI, SF-36, HRQoL e FSS
- Evaluation of Somatosensory Evoked Potential by Posterior Tibial and Medial Nerve stimulation to investigate the somatosensory pathway involvement.
- Clinical and Neurophysiological evaluation of Spasticity (if present): Ashworth Scale and H/M ratio and HReflex Vibratory Inhibition.
- Collection of blood sample to evaluate activity of Fatty Acid Amide Hydrolase (FAAH) in platelets. Second Day
- First Anodal or Sham Direct Current Stimulation Treatment Session (sDCS)
- Neurophysiological acquisition of Nociceptive Withdrawal Reflex (NWR) and NWR Temporal Summation (see 'Neurophysiological Acquisition' Session for details) before and after 30 and 60 minutes the first sDCS treatment
- sDCS Treatment After evaluation at T0 patients will undergo 10 daily sDCS treatment, 5 days a week (see sDCS treatment session for details).
- Evaluation after 10 days of treatment - T1
- Administration of NPSI, SF-36, HRQoL e FESS
- Clinical and Neurophysiological evaluation of Spasticity (if present): Ashworth Scale and H/M ratio and HReflex Vibratory Inhibition.
- Collection of blood sample to evaluate activity of Fatty Acid Amide Hydrolase (FAAH) in platelets.
- Neurophysiological acquisition of Nociceptive Withdrawal Reflex (NWR) and NWR Temporal Summation
- Evaluation after 1 month from the end of treatment - T2
- Administration of NPSI, SF-36, HRQoL e FESS
- Clinical and Neurophysiological evaluation of Spasticity (if present): Ashworth Scale and H/M ratio and HReflex Vibratory Inhibition.
- Collection of blood sample to evaluate activity of Fatty Acid Amide Hydrolase (FAAH) in platelets.
- Neurophysiological acquisition of Nociceptive Withdrawal Reflex (NWR) and NWR Temporal Summation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Experimental treatmentAnodal 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. |
| Placebo treatment | Placebo comparator | Other: Placebo treatmentFor sham sDCS (placebo), electrodes will be placed as for active stimulation, but the stimulator will automatically turn off after 10 s. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- Any form of headache
- Cognitive impairment (Minimental State Examination <= 21)
- Psychiatry diseases, in particular depression (Back Depression Inventory Scale >15)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental treatmentAnodal DC stimulation (2 mA, 20 min) will be delivered by a constant direct current electrical stimulator connected to a pair of electrodes | Other | Experimental Treatment |
| Placebo treatmentElectrodes will be placed as for active stimulation, but the stimulator will automatically turn off after 10 s | Other | Placebo treatment |
Primary outcome
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.
2 secondary outcomes
Central endocannabinoid level as determined by Activity of Fatty Acid Amide Hydrolase (FAAH) in platelets
Time frame: 30 days
Spasticity as determined by Ashworth Scale
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Background: PubMed 15365151Solaro 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.
- Background: PubMed 17928147O'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.
- Background: PubMed 16002441Nitsche 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.
- Background: PubMed 18525028Ferrucci 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.
- Background: PubMed 16499758Fregni 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.
- Background: PubMed 21494222O'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.
- Background: PubMed 16283615Polman 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.
- Background: PubMed 15009162Cruccu 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.
- Background: PubMed 16386347Sandrini 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.
- Derived from this study: PubMed 30809137Berra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Sandrini, MD principal investigator
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental treatment in people with Multiple Sclerosis, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cinzia Fattore, MD (+39 0382 380818, cinzia.fattore@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sDCS efficacy in pain as determined by NPSI and NRS scale (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02331654, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.