Multiple SclerosisNCT03389217
Efficacy of tDCS on Pain in Multiple Sclerosis
A study testing Real-tDCS + rehabilitation programme in people with Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Pain is a common symptom experienced by people with MS and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Pain in people with MS has the potential to become chronic, as a consequence of neuronal reorganization. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Real-tDCS + rehabilitation programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 1 May 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- chronic pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain, lasting more than 3 months with a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception;
- lack of MS worsening in the three months just before the intervention period;
- cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30.
Who cannot join
- worsening of MS-related conditions or changes in drug therapy or any other confounding factor during the study;
- rehabilitation treatments or Botulinum toxin injections during the three months preceding the start of the study;
- intracranial metal implants that can be stimulated, incorrectly positioned, or overheated by the electric current;
- severe cardiopulmonary, renal, and hepatic diseases;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ferrara University Hospital
Ferrara, 44124
Andrea Baroni, PT, +390532238720, brnndr3@unife.it
Sofia Straudi, MD, PhD
About this study
Official title: Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial
Pain is a common symptom experienced by people with MS and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Pain in people with MS has the potential to become chronic, as a consequence of neuronal reorganization. Transcranial Direct Current Stimulation (tDCS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining tDCS with rehabilitation treatment may have effect in reducing pain in people with MS. This is a pilot randomized control trial to test the effects of tDCS in MS-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with physical functioning), catastrophizing, emotional functioning and quality of life. Furthermore, we will explore the effects on pressure pain threshold and EEG recording. Correlations between sample characteristics and pain features will be investigated. Considering role of tDCS on neuropsychological functions, selective attention will be assessed.
- Conditions
- Multiple Sclerosis
- Being tested
- Real-tDCS + rehabilitation programme, Sham-tDCS + rehabilitation programme
- Keywords
- Multiple Sclerosis, Pain, Transcranial Direct Current Stimulation, tDCS
- Medical subject headings
- Multiple Sclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-tDCS + rehabilitation programmeDevice
tDCS stimulation will be delivered using a constant current stimulator, with rechargeable batteries. The active electrode will be placed on the left dorsolateral prefrontal cortex (DLPFC) and the reference electrode will be placed over the controlateral supraorbital region. The direct current will be delivered through a pair of sponge electrodes with a surface of 35 cm2 (7 × 5), soaked in saline solution. This continuous stimulation will last 30 minutes, with an intensity of 1 mA. Rehabilitation programme will last for 30 minutes and includes specific exercises for prevention and management of pain. All the subjects enrolled will receive treatments for 4 weeks. During the first week the experimental group underwent tDCS daily (Monday-Friday) and rehabilitation programme 3 days per week. tDCS will be delivered before rehabilitation treatment. During the second, third and fourth week subjects will receive only rehabilitation treatment, 3 days per week.
Sham-tDCS + rehabilitation programmeDevice
The control group will receive the same protocol treatment but they underwent sham-tDCS during the first week of treatment. For sham condition tDCS, current was delivered for only 30 seconds and then the current was discontinued, but the tDCS apparatus was left in place for the same time as active tDCS (30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Real-tDCS + rehabilitation programme | Experimental | The real transcranial Direct Current Stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 minutes over the the left dorsolateral prefrontal cortex and rehabilitation programme for prevention and management of pain. Receives: Device: Real-tDCS + rehabilitation programme |
| Sham-tDCS + rehabilitation programme | Active comparator | The sham transcranial Direct Current Stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 s over left dorsolateral prefrontal cortex and rehabilitation programme for prevention and management of pain. Receives: Device: Sham-tDCS + rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
Core outcome measure of pain intensity in chronic pain treatments' clinical trials
Measured: 4 weeks
Secondary outcomes (11)
Short Form McGill Pain Questionnaire (SF-MPQ)
Assessment of sensory and affective dimensions of typical whole-body pain intensity.
Measured: 1 week, 4 weeks, 8 weeks
Brief Pain Inventory (BPI)
Assessment of the extent to which pain interferes with general activity, mood, walking, work, relationship with others, sleep, and enjoyment of life.
Measured: 1 week, 4 weeks, 8 weeks
Pain Catastrophizing Scale (PCS)
Assessment of a tendency to misinterpret or exaggerate apparently threatening situations that can lead to increased sensitivity to pain.
Measured: 1 week, 4 weeks, 8 weeks
Coping Strategies Questionnaire (CSQ)
Assessment of the frequency of coping strategies in response to pain.
Measured: 1 week, 4 weeks, 8 weeks
Beck Depression Inventory II (BDI-II)
Assessment of severity of common depressive symptoms.
Measured: 1 week, 4 weeks, 8 weeks
MS Quality of Life - 54 (MSQOL-54)
Multidimensional health-related quality of life measure that combines both generic and MS-specific items
Measured: 1 week, 4 weeks, 8 weeks
Fatigue Severity Scale (FSS)
Assessment of common features of fatigue in patients with multiple sclerosis
Measured: 1 week, 4 weeks, 8 weeks
Go/No-go Task
Assessment of selective attention
Measured: 1 week, 4 weeks, 8 weeks
Patient Global Impression of Change (PGIC)
Measure of participants' assessment of the clinical importance of their improvement or worsening over the course of a treatment
Measured: 1 week, 4 weeks, 8 weeks
Pressure Pain Threshold (PPT)
PPT is measured to test presence of widespread pressure hyperalgesia as sign of abnormal pain processing.
Measured: 1 week, 4 weeks, 8 weeks
Electroencephalography (EEG) recordings
EEG data will be recorded to test presence of particular brain activity in condition of pain chronicity and catastrophization.
Measured: 1 week, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, University Hospital of Ferrara
- Investigators
- Sofia Straudi, MD, PhD, Study director, Ferrara Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389217
- Sponsor's protocol ID
- MS_tDCS_Pain
- Status last verified
- May 2022
- First submitted
- 16 Nov 2017
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of tDCS on Pain Experience in People With Multiple Sclerosis: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03389217
- Acronym / sponsor ID
- MS_tDCS_Pain
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Pain, Transcranial Direct Current Stimulation, tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 Jan 2018 (actual)
- 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 is a common symptom experienced by people with MS and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Pain in people with MS has the potential to become chronic, as a consequence of neuronal reorganization. Transcranial Direct Current Stimulation (tDCS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining tDCS with rehabilitation treatment may have effect in reducing pain in people with MS. This is a pilot randomized control trial to test the effects of tDCS in MS-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with physical functioning), catastrophizing, emotional functioning and quality of life. Furthermore, we will explore the effects on pressure pain threshold and EEG recording. Correlations between sample characteristics and pain features will be investigated. Considering role of tDCS on neuropsychological functions, selective attention will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-tDCS + rehabilitation programme | Experimental | Device: Real-tDCS + rehabilitation programmeThe real transcranial Direct Current Stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 minutes over the the left dorsolateral prefrontal cortex and rehabilitation programme for prevention and management of pain. |
| Sham-tDCS + rehabilitation programme | Active comparator | Device: Sham-tDCS + rehabilitation programmeThe sham transcranial Direct Current Stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 s over left dorsolateral prefrontal cortex and rehabilitation programme for prevention and management of pain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic pain defined as a constant or intermittent sensory symptom with unpleasant feelings or pain, lasting more than 3 months with a minimum score of 3 points on the Numeric Rating Scale (NRS) for pain perception;
- lack of MS worsening in the three months just before the intervention period;
- cognitive functioning to give informed consent identified by a Mini-Mental Status Examination (MMSE) score ≥ 24/30.
Key exclusion criteria (5 listed)
- worsening of MS-related conditions or changes in drug therapy or any other confounding factor during the study;
- rehabilitation treatments or Botulinum toxin injections during the three months preceding the start of the study;
- intracranial metal implants that can be stimulated, incorrectly positioned, or overheated by the electric current;
- severe cardiopulmonary, renal, and hepatic diseases;
- pregnancy.
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 |
|---|---|---|
| Real-tDCS + rehabilitation programmetDCS stimulation will be delivered using a constant current stimulator, with rechargeable batteries. The active electrode will be placed on the left dorsolateral prefrontal cortex (DLPFC) and the reference electrode will be placed over the controlateral supraorbital region. The direct current will be delivered through a pair of sponge electrodes with a surface of 35 cm2 (7 × 5), soaked in saline solution. This continuous stimulation will last 30 minutes, with an intensity of 1 mA. Rehabilitation programme will last for 30 minutes and includes specific exercises for prevention and management of pain. All the subjects enrolled will receive treatments for 4 weeks. During the first week the experimental group underwent tDCS daily (Monday-Friday) and rehabilitation programme 3 days per week. tDCS will be delivered before rehabilitation treatment. During the second, third and fourth week subjects will receive only rehabilitation treatment, 3 days per week. | Device | Real-tDCS + rehabilitation programme |
| Sham-tDCS + rehabilitation programmeThe control group will receive the same protocol treatment but they underwent sham-tDCS during the first week of treatment. For sham condition tDCS, current was delivered for only 30 seconds and then the current was discontinued, but the tDCS apparatus was left in place for the same time as active tDCS (30 minutes) | Device | Sham-tDCS + rehabilitation programme |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: 4 weeks
Core outcome measure of pain intensity in chronic pain treatments' clinical trials
11 secondary outcomes
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 1 week, 4 weeks, 8 weeks
Brief Pain Inventory (BPI)
Time frame: 1 week, 4 weeks, 8 weeks
Pain Catastrophizing Scale (PCS)
Time frame: 1 week, 4 weeks, 8 weeks
Coping Strategies Questionnaire (CSQ)
Time frame: 1 week, 4 weeks, 8 weeks
Beck Depression Inventory II (BDI-II)
Time frame: 1 week, 4 weeks, 8 weeks
MS Quality of Life - 54 (MSQOL-54)
Time frame: 1 week, 4 weeks, 8 weeks
Fatigue Severity Scale (FSS)
Time frame: 1 week, 4 weeks, 8 weeks
Go/No-go Task
Time frame: 1 week, 4 weeks, 8 weeks
Patient Global Impression of Change (PGIC)
Time frame: 1 week, 4 weeks, 8 weeks
Pressure Pain Threshold (PPT)
Time frame: 1 week, 4 weeks, 8 weeks
Electroencephalography (EEG) recordings
Time frame: 1 week, 4 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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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.
Sofia Straudi, MD, PhD study director
Ferrara Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-tDCS + rehabilitation programme in people with Multiple Sclerosis, run by University Hospital of Ferrara 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 3 inclusion and 5 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 25 May 2022. 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. 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 Sofia Straudi, MD, PhD (+390532238720, s.straudi@ospfe.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2022.