Multiple SclerosisNCT03870048
tDCS to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis
A study testing transcranial direct current stimulation in people with Multiple Sclerosis, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with MS. The investigators will conduct tDCS or sham on 5 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically diagnosed with Multiple Sclerosis
- 18-70 yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2-6)
- Self-reported differences in function between legs
- Able to walk for 6 min
- Presenting with chronic, drug-resistant, neuropathic pain.
Who cannot join
- Relapse within last 60 days
- High risk for cardiovascular disease (ACSM risk classification)
- Changes in disease modifying medications within last 45 days
- Concurrent neurological/neuromuscular disease
- Hospitalization within last 90 days
- Diagnosed depression
- Inability to understand/sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with MS. The investigators will conduct tDCS or sham on 5 consecutive days. They will evaluate pain and fatigue with specific questionnaires and measure fatigability with an isokinetic device.
The research question is whether tDCS can lessen neuropathic pain and increase fatigue resistance in people with MS. It is hypothesized, that less neuropathic pain and increased fatigue resistance after the tDCS sessions.
Read the detailed description
Prospective participants, men and women with MS, will be recruited. To accomplish this study, 20 participants will need to complete 2 randomly-ordered blocks of protocols (tDCS or sham), separated by at least one week. Each block involves 5 daily sessions at the INPL. The duration of each session will be approximately one hour and will be completed at the same time of day for each subject. The investigators expect data collection to last 6 months. Each session will be a combination of questionnaires, leg strength assessment, and an isokinetic fatigue test.
Leg strength assessment: Isokinetic (concentric/concentric) flexion and extension of the knee at 60°/s will performed five times to determine the more-MS affected leg. When strength difference between the left and right legs is less than 10%, the more affected side will be based on the participant's self-report.
Isokinetic fatigue test: Participant's will perform 40 consecutive repetitions of isokinetic concentric/concentric flexion and extension of the knee on the more-affected leg at 120 degree/sec.
In the initial session (i.e., Block 1, Session 1) subjects will 1) be consented, 2) complete the Patient Determined Disease Steps (PDDS) questionnaire, 3) the Fatigue Severity Scale (FSS), 4) Neuropathic Pain Questionnaire (NPQ), 5) Visual analog scale (VAS), 6) perform a leg strength assessment, 7) perform an isokinetic fatigue test, and 8) undergo either tDCS or sham treatment, depending on the randomized block.
tDCS treatment protocol: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. The two protocols blocks (tDCS or sham) will be performed in randomized order.
tDCS Block: The participant will receive tDCS for 20 min at an intensity of 2 mA while seated comfortably and quietly in a room. The intensity will start at 0 mA and will be incrementally increased to 2mA over the initial 30 seconds. At the 19:30 minute time point, the current will gradually be reduced from 2 mA to 0 mA.
Sham block: Identical to the tDCS block, except the participants will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 for the remainder of the 20 minutes.
The remaining sessions of first block (i.e. Block 1, Sessions 2-5) will be as follows: In Sessions 2 and 4, the subjects get the tDCS or sham treatment, after which they will complete the fatigue and pain questionnaires (FSS and NPQ). Sessions 3 will be the same as Sessions 2 and 4, except that the isokinetic fatigue test will be performed at the beginning (i.e., before the tDCS or sham treatment). Session 5 will start with tDCS or sham treatment, then the isokinetic fatigue test, and finally the fatigue and pain questionnaires.
Block 2 will be completed in the same manner as Block 1, except that the subjects will not redo the PDDS, VAS, and BDI in Session 1 and the treatment will shift to either tDCS or sham, depending on how the blocks were randomized.
Duration of Relief - If the participant indicates any reduction in pain following the previous day's tDCS session, they will be asked to estimate how long their pain was reduced following the session. Additionally, one week following the last testing session (i.e., Block 2, Session 5), participants will be contacted via telephone and asked the following questions:
- Was tDCS effective at reducing the subject's pain?
- If so, how long did the subject notice a reduction in pain following your final tDCS session?
- Have the subject reduced his/her use of pain relieving medications since your last tDCS session?
- Conditions
- Multiple Sclerosis
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants/tDCS or SHAM | Experimental | tDCS Block: The participant will receive tDCS for 20 min at an intensity of 2 mA while seated comfortably and quietly in a room. The intensity will start at 0 mA and will be incrementally increased to 2mA over the initial 30 seconds. At the 19:30 minute time point, the current will gradually be reduced from 2 mA to 0 mA.
Sham block: Identical to the tDCS block, except the participants will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 for the remainder of the 20 minutes. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Questionnaire (NPQ) Contains 12 Items.
The participant is asked to use items to rate their pain as it usually feels. They have to indicate a number which represents their pain on each scale. For example, if someone has no burning pain, the person would rate the first item "0". If the person has the worst burning pain imaginable, he/she would rate it "100". If neither of those fits his/her pain because it is in between, the participant has to choose a number which fits his/her pain.
Measured: 2 Months
Secondary outcomes (1)
Fatigue Severity Scale (FSS) Contains Nine Statements That Attempt to Explore Severity of Fatigue Symptoms.
The FSS questionnaire The participant has to read each statement and circle a number from 1 to 7, depending on how appropriate they felt the statement applied to them over the preceding week. A low value indicates that the statement is not very appropriate whereas a high value indicates agreement (1 disagree, 7 agree).
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start15 Apr 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- jkamholz, Workman, Craig D., PhD
- Responsible party
- Principal investigator, Thorsten Rudroff, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870048
- Sponsor's protocol ID
- 201812729
- Status last verified
- Aug 2022
- First submitted
- 7 Mar 2019
- Last updated
- 25 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03870048
- Acronym / sponsor ID
- 201812729
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- jkamholz, Workman, Craig D., PhD
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 25 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with MS. The investigators will conduct tDCS or sham on 5 consecutive days. They will evaluate pain and fatigue with specific questionnaires and measure fatigability with an isokinetic device.
The research question is whether tDCS can lessen neuropathic pain and increase fatigue resistance in people with MS. It is hypothesized, that less neuropathic pain and increased fatigue resistance after the tDCS sessions.
Detailed description
Prospective participants, men and women with MS, will be recruited. To accomplish this study, 20 participants will need to complete 2 randomly-ordered blocks of protocols (tDCS or sham), separated by at least one week. Each block involves 5 daily sessions at the INPL. The duration of each session will be approximately one hour and will be completed at the same time of day for each subject. The investigators expect data collection to last 6 months. Each session will be a combination of questionnaires, leg strength assessment, and an isokinetic fatigue test.
Leg strength assessment: Isokinetic (concentric/concentric) flexion and extension of the knee at 60°/s will performed five times to determine the more-MS affected leg. When strength difference between the left and right legs is less than 10%, the more affected side will be based on the participant's self-report.
Isokinetic fatigue test: Participant's will perform 40 consecutive repetitions of isokinetic concentric/concentric flexion and extension of the knee on the more-affected leg at 120 degree/sec.
In the initial session (i.e., Block 1, Session 1) subjects will 1) be consented, 2) complete the Patient Determined Disease Steps (PDDS) questionnaire, 3) the Fatigue Severity Scale (FSS), 4) Neuropathic Pain Questionnaire (NPQ), 5) Visual analog scale (VAS), 6) perform a leg strength assessment, 7) perform an isokinetic fatigue test, and 8) undergo either tDCS or sham treatment, depending on the randomized block.
tDCS treatment protocol: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. The two protocols blocks (tDCS or sham) will be performed in randomized order.
tDCS Block: The participant will receive tDCS for 20 min at an intensity of 2 mA while seated comfortably and quietly in a room. The intensity will start at 0 mA and will be incrementally increased to 2mA over the initial 30 seconds. At the 19:30 minute time point, the current will gradually be reduced from 2 mA to 0 mA.
Sham block: Identical to the tDCS block, except the participants will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 for the remainder of the 20 minutes.
The remaining sessions of first block (i.e. Block 1, Sessions 2-5) will be as follows: In Sessions 2 and 4, the subjects get the tDCS or sham treatment, after which they will complete the fatigue and pain questionnaires (FSS and NPQ). Sessions 3 will be the same as Sessions 2 and 4, except that the isokinetic fatigue test will be performed at the beginning (i.e., before the tDCS or sham treatment). Session 5 will start with tDCS or sham treatment, then the isokinetic fatigue test, and finally the fatigue and pain questionnaires.
Block 2 will be completed in the same manner as Block 1, except that the subjects will not redo the PDDS, VAS, and BDI in Session 1 and the treatment will shift to either tDCS or sham, depending on how the blocks were randomized.
Duration of Relief - If the participant indicates any reduction in pain following the previous day's tDCS session, they will be asked to estimate how long their pain was reduced following the session. Additionally, one week following the last testing session (i.e., Block 2, Session 5), participants will be contacted via telephone and asked the following questions:
- Was tDCS effective at reducing the subject's pain?
- If so, how long did the subject notice a reduction in pain following your final tDCS session?
- Have the subject reduced his/her use of pain relieving medications since your last tDCS session?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants/tDCS or SHAM | Experimental | Device: transcranial direct current stimulationtDCS Block: The participant will receive tDCS for 20 min at an intensity of 2 mA while seated comfortably and quietly in a room. The intensity will start at 0 mA and will be incrementally increased to 2mA over the initial 30 seconds. At the 19:30 minute time point, the current will gradually be reduced from 2 mA to 0 mA. Sham block: Identical to the tDCS block, except the participants will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 for the remainder of the 20 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically diagnosed with Multiple Sclerosis
- 18-70 yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2-6)
- Self-reported differences in function between legs
- Able to walk for 6 min
- Presenting with chronic, drug-resistant, neuropathic pain.
Key exclusion criteria (7 listed)
- Relapse within last 60 days
- High risk for cardiovascular disease (ACSM risk classification)
- Changes in disease modifying medications within last 45 days
- Concurrent neurological/neuromuscular disease
- Hospitalization within last 90 days
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 |
|---|---|---|
| transcranial direct current stimulationA tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. | Device | All Study Participants/tDCS or SHAM |
Primary outcome
Neuropathic Pain Questionnaire (NPQ) Contains 12 Items.
Time frame: 2 Months
The participant is asked to use items to rate their pain as it usually feels. They have to indicate a number which represents their pain on each scale. For example, if someone has no burning pain, the person would rate the first item "0". If the person has the worst burning pain imaginable, he/she would rate it "100". If neither of those fits his/her pain because it is in between, the participant has to choose a number which fits his/her pain.
1 secondary outcome
Fatigue Severity Scale (FSS) Contains Nine Statements That Attempt to Explore Severity of Fatigue Symptoms.
Time frame: 2 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Multiple Sclerosis, run by University of Iowa at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 25 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Questionnaire (NPQ) Contains 12 Items. (time frame: 2 Months). 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 Aug 2022.