Multiple SclerosisNCT04016844
tDCS and Glucose Uptake in Leg Muscles
A study of Multiple Sclerosis, run by University of Iowa at 1 site in United States.
Trial summary
This study is to examine the efficacy of tDCS to improving walking in people with Multiple Sclerosis (PwMS). Our study compromises 1 group of subjects with MS which will attend the lab for three sessions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2019to 1 Oct 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 (MS)
- 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 20 min.
Who cannot join
- MS relapse within last 60 days
- inability to fast for 6 hours
- hyperglycemia (fasting blood sugar > 200 mg/dL)
- insulin-dependent diabetes
- high risk for cardiovascular disease (ACSM risk classification)
- changes in disease-modifying medications within last 45 days
Show all 11Show fewer
- concurrent neurological/neuromuscular disease
- hospitalization within last 90 days
- diagnosed depression
- inability to understand/sign informed consent, pregnant, history of seizure disorders (or on medications known to lower seizure threshold)
- hydrocephalus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation to Reduce Asymmetric Glucose Uptake in Leg Muscles of Persons With Multiple Sclerosis
This study is to examine the efficacy of tDCS to improving walking in people with Multiple Sclerosis (PwMS).
Our study compromises 1 group of subjects with MS which will attend the lab for three sessions. In the first session, subjects will be consented, complete the Patient Determined Disease Steps (PDDS), the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. The second and third sessions will involve whole-body FDG PET imaging. During each of these sessions, the subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS or SHAM, in a blinded manner, will be applied to the motor cortex (M1) corresponding to the more-affected leg. Approximately 2 minutes into the walking, [18F]fluorodeoxyglucose (FDG) will be administered by IV injection. Immediately after the walking is completed, the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired for the evaluation of glucose metabolism in the brain, spine, and lower extremities. The third session will be identical to the second session with the exception that the opposite condition (tDCS or SHAM) will be used.
Read the detailed description
Prospective participants, men and women with MS, will be recruited. The plan is to enroll up to 30 to get 20 evaluable subjects. To accomplish this study, all participants will need to complete 3 sessions. The first session at the INPL and sessions 2 and 3 at PET Imaging Center (0911ZJPP) and the PET Imaging lab in Pappajohn Biomedical Discovery Building. Session 2 and 3 are separated by 5-8 days. The duration of each session will be approximately 120 minutes. We expect data collection to last 6 months.
In the first session, subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. When leg strength difference is less than 10%, the more affected side will be based on self-report. The second and the third sessions will involve 20 min walking on a treadmill at a self-selected speed during which time tDCS or SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg and [18F]fluorodeoxyglucose will be administered. At the end of the walking period, the subject will be imaged on a PET/CT scanner from top of head to toes.
Prior to sessions 2 and 3, all subjects will be asked to fast (water and medication can be taken during this time) for a minimum of 6 hours prior to the FDG administration. In addition, the blood glucose level will be checked (via Accuchek) prior to FDG administration and the level must be equal to or less than 200 mg/dL in order to proceed with the FDG administration on that day. At the beginning of session 2 and 3, the subject will be weighed and height measured, have a blood glucose level determined via Accuchek as described above, undergo a urine pregnancy test if the subject is of child-bearing potential, and have an IV catheter inserted for FDG administration. The subject will then be moved to the PET Scanner area in Pappajohn Biomedical Discovery Building. The subject will be asked to use the restroom prior to walking on the treadmill. 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 participant will receive tDCS or SHAM throughout the walking (i.e., for 20 min). In the tDCS trial, the intensity will start at 0 mA and will increase to 3 mA over the first 30 seconds. In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0.
Two min into the walking test on the treadmill, 10 mCi of [18F]-FDG will be injected IV. Then, the walking test continues until 20 min is reached. When the walking test is completed, the tDCS device will be removed and the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired.
Ratings of perceived exertion (RPE) will be recorded with the modified Borg 10-point scale (Borg, 1982). The subjects will be instructed to estimate the effort during walking. The scale will be anchored so that 0 denotes the resting state and 10 represents the strongest effort.
No long-term follow-up will be done.
- Conditions
- Multiple Sclerosis
- Being tested
- transcranial direct current stimulation or SHAM
- Keywords
- Multiple Scerosis, PET, tDCS
- 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 stimulation or SHAMDevice
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.
In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0. The same tDCS device (Soterix) will be used.
| Study group | Role | What they receive |
|---|---|---|
| tDCS first then SHAM effects on glucose uptake in leg muscles | Experimental | tDCS Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg.
Sham Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg. Receives: Device: transcranial direct current stimulation or SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Uptake in Leg Muscles
Participants are walking on a treadmill with tDCS or SHAM, followed by a positron emission tomography (PET) scan to measure glucose uptake in leg muscles. SUV asymmetry indices (AIs) were calculated to determine the magnitude of asymmetry between the more- and less-affected legs with a previously used equation: ((less-affected side - more-affected side)/((0.5) × (less-affected side + more- affected side)) × 100). An AI value ≥ 10% was considered asymmetric.
Measured: Six Months
Secondary outcomes (1)
Ratings of Perceived Exertion (RPE)
Ratings of perceived exertion (RPE) will be recorded with the modified Borg 10-point scale (Borg, 1982). The subjects will be instructed to estimate their effort during walking. The scale will be anchored so that 0 denotes the resting state and 10 represents the strongest effort they are able to perform.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start6 Dec 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 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
- Model description
- Participants will receive tDCS in one session and SHAM in the other session.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorsten Rudroff, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016844
- Sponsor's protocol ID
- 201905825
- Status last verified
- Jan 2023
- First submitted
- 8 Jul 2019
- Last updated
- 25 Jan 2023
- 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 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation to Reduce Asymmetric Glucose Uptake in Leg Muscles of Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04016844
- Acronym / sponsor ID
- 201905825
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Scerosis, PET, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to examine the efficacy of tDCS to improving walking in people with Multiple Sclerosis (PwMS).
Our study compromises 1 group of subjects with MS which will attend the lab for three sessions. In the first session, subjects will be consented, complete the Patient Determined Disease Steps (PDDS), the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. The second and third sessions will involve whole-body FDG PET imaging. During each of these sessions, the subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS or SHAM, in a blinded manner, will be applied to the motor cortex (M1) corresponding to the more-affected leg. Approximately 2 minutes into the walking, [18F]fluorodeoxyglucose (FDG) will be administered by IV injection. Immediately after the walking is completed, the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired for the evaluation of glucose metabolism in the brain, spine, and lower extremities. The third session will be identical to the second session with the exception that the opposite condition (tDCS or SHAM) will be used.
Detailed description
Prospective participants, men and women with MS, will be recruited. The plan is to enroll up to 30 to get 20 evaluable subjects. To accomplish this study, all participants will need to complete 3 sessions. The first session at the INPL and sessions 2 and 3 at PET Imaging Center (0911ZJPP) and the PET Imaging lab in Pappajohn Biomedical Discovery Building. Session 2 and 3 are separated by 5-8 days. The duration of each session will be approximately 120 minutes. We expect data collection to last 6 months.
In the first session, subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. When leg strength difference is less than 10%, the more affected side will be based on self-report. The second and the third sessions will involve 20 min walking on a treadmill at a self-selected speed during which time tDCS or SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg and [18F]fluorodeoxyglucose will be administered. At the end of the walking period, the subject will be imaged on a PET/CT scanner from top of head to toes.
Prior to sessions 2 and 3, all subjects will be asked to fast (water and medication can be taken during this time) for a minimum of 6 hours prior to the FDG administration. In addition, the blood glucose level will be checked (via Accuchek) prior to FDG administration and the level must be equal to or less than 200 mg/dL in order to proceed with the FDG administration on that day. At the beginning of session 2 and 3, the subject will be weighed and height measured, have a blood glucose level determined via Accuchek as described above, undergo a urine pregnancy test if the subject is of child-bearing potential, and have an IV catheter inserted for FDG administration. The subject will then be moved to the PET Scanner area in Pappajohn Biomedical Discovery Building. The subject will be asked to use the restroom prior to walking on the treadmill. 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 participant will receive tDCS or SHAM throughout the walking (i.e., for 20 min). In the tDCS trial, the intensity will start at 0 mA and will increase to 3 mA over the first 30 seconds. In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0.
Two min into the walking test on the treadmill, 10 mCi of [18F]-FDG will be injected IV. Then, the walking test continues until 20 min is reached. When the walking test is completed, the tDCS device will be removed and the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired.
Ratings of perceived exertion (RPE) will be recorded with the modified Borg 10-point scale (Borg, 1982). The subjects will be instructed to estimate the effort during walking. The scale will be anchored so that 0 denotes the resting state and 10 represents the strongest effort.
No long-term follow-up will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive tDCS in one session and SHAM in the other session.
| Arm | Type | Receives |
|---|---|---|
| tDCS first then SHAM effects on glucose uptake in leg muscles | Experimental | Device: transcranial direct current stimulation or SHAMtDCS Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg. Sham Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medically diagnosed with Multiple Sclerosis (MS)
- 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 20 min.
Key exclusion criteria (11 listed)
- MS relapse within last 60 days
- inability to fast for 6 hours
- hyperglycemia (fasting blood sugar > 200 mg/dL)
- insulin-dependent diabetes
- high risk for cardiovascular disease (ACSM risk classification)
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 stimulation or SHAMA 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. In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0. The same tDCS device (Soterix) will be used. | Device | tDCS first then SHAM effects on glucose uptake in leg muscles |
Primary outcome
Glucose Uptake in Leg Muscles
Time frame: Six Months
Participants are walking on a treadmill with tDCS or SHAM, followed by a positron emission tomography (PET) scan to measure glucose uptake in leg muscles. SUV asymmetry indices (AIs) were calculated to determine the magnitude of asymmetry between the more- and less-affected legs with a previously used equation: ((less-affected side - more-affected side)/((0.5) × (less-affected side + more- affected side)) × 100). An AI value ≥ 10% was considered asymmetric.
1 secondary outcome
Ratings of Perceived Exertion (RPE)
Time frame: Six Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- 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 of 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 3 inclusion and 11 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 Jan 2023. 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 Jan 2023). 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?
Glucose Uptake in Leg Muscles (time frame: Six 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 Jan 2023.