Multiple SclerosisNCT04033133
Cerebral Blood Flow and tDCS
A study testing tDCS in people with Multiple Sclerosis, run by University of Iowa at 1 site in United States.
Trial summary
With this study, the investigators will substantiate if regional cerebral blood flow (CBF) is affected by tDCS, assess the amount of CBF change in relation to different currents, and measure differences in regional CBF under stimulation reactivity between healthy subjects and people with Multiple Sclerosis (PwMS)using… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2019to 15 Aug 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of multiple sclerosis by a neurologist
- No change in MS-specific medication (disease modification drugs) in the last three months
- Healthy enough to complete the protocol based on information obtained from a clinical exam and past medical history.
- An expanded disability status scale (EDSS) below 5.5
- Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
- Able to use and be contacted by telephone
- Able to speak, read, and understand English, and complete a questionnaire in English
- Body mass index <30 kg/m2
Who cannot join
- A relapse of disease symptoms in the last three months
- History / presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
- Alcohol dependence or abuse (>2 drinks/day), or present history (last six months) of drug abuse
- History of significant traumatic brain injury or hydrocephalus
- Currently pregnant
- Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state
Show all 16Show fewer
- Claustrophobia
- A subject will be excluded if he/she has a contraindication to Magnetic Resonance scanning, e.g., implanted metal clips or wires, which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
- Examples include:
- Aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker or autodefibrillator
- Cochlear implant
- Ocular foreign body (e.g., metal shavings)
- Any implanted device (pumps, infusion devices, etc.)
- Shrapnel injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Human Physiology
Iowa City, Iowa, 52242
About this study
Official title: Cerebral Blood Flow in People With Multiple Sclerosis During Transcranial Direct Current Stimulation
With this study, the investigators will substantiate if regional cerebral blood flow (CBF) is affected by tDCS, assess the amount of CBF change in relation to different currents, and measure differences in regional CBF under stimulation reactivity between healthy subjects and people with Multiple Sclerosis (PwMS)using Water O-15 PET (Water Oxygen-15 Positron EmissionTomography) imaging. The objective is to investigate the changes in regional CBF after transcranial direct current stimulation (tDCS) at different intensities (1 mA, 2 mA, 3 mA, 4 mA) in healthy subjects and PwMS. The design is a cross-sectional proof of principle study in 10 healthy subjects and 10 PwMS.
Relative regional brain CBF (rCBF) will be analyzed semi-quantitatively using voxel-wise and region of interest-based approaches. Changes in CBF associated with tDCS-application will be calculated with a general linear model in a ramp function of the task-specific rCBF, according to previous work in our group using a glucose analogue. Exploratory statistical testing will be done using a paired samples t-test between task and rest conditions and unpaired t-tests between PwMS and healthy controls at the same intensities.
With this study the investigators will be able to dose-dependently measure real-time rCBF changes after non-invasively stimulating the superficial parts of the dorsolateral prefrontal cortex (DLPFC), a commonly used target in therapeutic tDCS applications. This will provide further insight into whether tDCS is capable of inducing changes in rCBF.
Read the detailed description
Aim 1: To determine the effects of different stimulation intensities on relative cerebral blood flow (rCBF).
Currently, researchers use tDCS as an interventional modality to modulate the excitability of the brain, with measureable changes in both motor evoked potentials and physical performances. However, because of the relatively large size of most electrodes, and the electrodynamics of the brain, it still remains unclear what specific brain structures are being stimulated and how the mechanics of stimulation (e.g., stimulation penetration and areas affected outside of target area) change with different intensities. The investigators hypothesize that regional CBF at the DLPFC (target area) will increase in a dose-dependent way with greater stimulation intensity. Furthermore, it is hypothesized that the areas surrounding the DLPFC will be increasingly affected by higher stimulation intensities.
Aim 2: To contrast the effects of transcranial direct current stimulation on relative cerebral blood flow between healthy subjects and people with Multiple Sclerosis.
PwMS typically present with glucose hypometabolism compared to their healthy peers and because CBF and glucose metabolism are highly coupled, a similar trend in CBF may be expected. Additionally, tDCS has been shown to be effective at increasing cortical excitability and glucose metabolism in both populations. However, what still remains uncertain is if PwMS and healthy subjects experience the same amount of increased activity for the same stimulation intensity. The investigators hypothesize that PwMS will experience a greater increase in rCBF at the DLPFC and surrounding areas than healthy controls for the same stimulation intensity.
Aim 3: To extend our understanding of the safety and efficacy of transcranial direct current stimulation at higher current intensities for healthy subjects and people with Multiple Sclerosis.
Despite some work on the feasibility and safety of performing tDCS at intensities > 2 mA (i.e., up to 4 mA), the convention for most tDCS studies is to use intensities less than or equal to 2 mA. This has been sufficient to illicit measurable effects in both excitability and performance outcomes. However, the potential benefits of increasing intensity to either enhance the effects of a given stimulation protocol (e.g., time or magnitude) or to potentially access deeper brain areas justifies further exploration of current intensities > 2 mA. It is also important to add to the safety protocol of higher intensities in healthy and clinical (e.g., PwMS) subjects. The investigators hypothesize that higher intensities (i.e., > 2 mA) will be well tolerated by both healthy subjects and PwMS. Additionally, the investigators hypothesize no serious adverse effects from higher stimulation intensities. The existing side-effects of tDCS at intensities less than or equal to 2 mA include low-grade occurrences of tingling, itching, and burning sensation at the electrode sites; a few subjects have reported short-lived (< 5 min) headaches. In a study testing the safety of higher intensities similar to those proposed here, these same side-effects were observed in 50% of the subjects. This rate of occurrence is slightly higher than studies using less than or equal to 2 mA, but the magnitudes of the negative effects were still well within safely tolerable limits and were all transient in nature.
I.6 Background and significance and/or Preliminary studies related to this project.
(do not indicate "see protocol") Transcranial direct current stimulation (tDCS) is a non-invasive and well-tolerated brain stimulation technique (1-4) that can modulate the cortical excitability of targeted brain regions (5) as well as cerebral blood flow (6) in a polarity-dependent manner.
Models of tDCS current flow (7,8) and findings from studies in which human functional magnetic resonance Imaging (fMRI) has been used to measure brain activity (9-11) suggest that tDCS can alter processing across large areas of the cortex. In this sense, the effects of tDCS are likely to be relatively broad. Thus, while the neural changes induced by tDCS are concentrated around regions of cortex closest to the electrodes (12), broader networks of functionally-connected regions may also be recruited (9,10,13,14). Furthermore, no systematic investigation has been done to determine the most efficacious current intensity for PwMS.
There is empirical evidence that tDCS with current intensity between 1 and 2 mA for 20-40 minutes for either single or multiple sessions can safely and effectively be administered to PwMS (15-20). Although tDCS with current intensities > 2 mA are considered safe 21, no studies have investigated how brain activity is affected during tDCS at intensities > 2 mA. Although the safety of higher intensity tDCS in PwMS may be initially assumed from previous work using subjects who have experienced a stroke (21), it has also been suggested that more studies on the safety of higher intensity stimulation in other populations are needed in order to exercise due diligence before widely prescribing intensities greater than the present convention (22).
The cerebral activation in PwMS has been investigated with [15O] water and with [15O] O2 PET (indexes oxygen metabolism)(23). Widespread reductions in cerebral blood flow and oxygen metabolism in both gray and white mater have been reported in PwMS (24). Furthermore, these studies indicate that the degree of oxygen metabolism reduction correlated with worse cognitive performance and expanded disability status scale (EDSS), and that the degree of cerebral oxygen hypometabolism was associated with the number of relapses (25).
A close coupling of perfusion and metabolism is assumed, reflecting oxidative phosphorylation of glucose as the predominant source of energy production. Consequently, CBF is often considered as an indirect measure of neuronal function and integrity (26). This is supported by the significant association of metabolism with regional CBF (rCBF) across different brain regions (27,28), and with global CBF (gCBF) across varying states of consciousness (29).
With this study, the investigators will be able to substantiate if rCBF is affected by tDCS, assess the amount of signal change in relation to different currents, and measure differences in CBF distribution under stimulation reactivity between healthy subjects and PwMS. The objective is to investigate the changes in rCBF after transcranial direct current stimulation at different intensities (1 mA, 2 mA, 3 mA, 4 mA) in healthy subjects and PwMS. The design is a cross-sectional proof of principle study in 10 healthy subjects and 10 PwMS.
- Conditions
- Multiple Sclerosis
- Being tested
- tDCS
- Keywords
- Multiple Sclerosis, tDCS, Cerebral Blood Flow
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Subjects will get tDCS at intensities of 0, 1, 2, 3, and 4 mA.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Experimental | People with MS get tDCS with different intensities. Receives: Device: tDCS |
| Healthy Subjects | Active comparator | Healthy subjects get tDCS with different intensities. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow
Cerebral Blood flow will be measured while subjects undergo tDCS at different intensities in the PET scanner.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start20 Dec 2019
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
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
- Crossover
- Model description
- People with Multiple Sclerosis and healthy controls will receive tDCS at different intensities while in the PET scanner.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 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
- NCT04033133
- Sponsor's protocol ID
- 201905826
- Status last verified
- Sep 2021
- First submitted
- 23 Jul 2019
- Last updated
- 28 Sep 2021
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow in People With Multiple Sclerosis During Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT04033133
- Acronym / sponsor ID
- 201905826
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, tDCS, Cerebral Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 25 Jul 2019 (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.
With this study, the investigators will substantiate if regional cerebral blood flow (CBF) is affected by tDCS, assess the amount of CBF change in relation to different currents, and measure differences in regional CBF under stimulation reactivity between healthy subjects and people with Multiple Sclerosis (PwMS)using Water O-15 PET (Water Oxygen-15 Positron EmissionTomography) imaging. The objective is to investigate the changes in regional CBF after transcranial direct current stimulation (tDCS) at different intensities (1 mA, 2 mA, 3 mA, 4 mA) in healthy subjects and PwMS. The design is a cross-sectional proof of principle study in 10 healthy subjects and 10 PwMS.
Relative regional brain CBF (rCBF) will be analyzed semi-quantitatively using voxel-wise and region of interest-based approaches. Changes in CBF associated with tDCS-application will be calculated with a general linear model in a ramp function of the task-specific rCBF, according to previous work in our group using a glucose analogue. Exploratory statistical testing will be done using a paired samples t-test between task and rest conditions and unpaired t-tests between PwMS and healthy controls at the same intensities.
With this study the investigators will be able to dose-dependently measure real-time rCBF changes after non-invasively stimulating the superficial parts of the dorsolateral prefrontal cortex (DLPFC), a commonly used target in therapeutic tDCS applications. This will provide further insight into whether tDCS is capable of inducing changes in rCBF.
Detailed description
Aim 1: To determine the effects of different stimulation intensities on relative cerebral blood flow (rCBF).
Currently, researchers use tDCS as an interventional modality to modulate the excitability of the brain, with measureable changes in both motor evoked potentials and physical performances. However, because of the relatively large size of most electrodes, and the electrodynamics of the brain, it still remains unclear what specific brain structures are being stimulated and how the mechanics of stimulation (e.g., stimulation penetration and areas affected outside of target area) change with different intensities. The investigators hypothesize that regional CBF at the DLPFC (target area) will increase in a dose-dependent way with greater stimulation intensity. Furthermore, it is hypothesized that the areas surrounding the DLPFC will be increasingly affected by higher stimulation intensities.
Aim 2: To contrast the effects of transcranial direct current stimulation on relative cerebral blood flow between healthy subjects and people with Multiple Sclerosis.
PwMS typically present with glucose hypometabolism compared to their healthy peers and because CBF and glucose metabolism are highly coupled, a similar trend in CBF may be expected. Additionally, tDCS has been shown to be effective at increasing cortical excitability and glucose metabolism in both populations. However, what still remains uncertain is if PwMS and healthy subjects experience the same amount of increased activity for the same stimulation intensity. The investigators hypothesize that PwMS will experience a greater increase in rCBF at the DLPFC and surrounding areas than healthy controls for the same stimulation intensity.
Aim 3: To extend our understanding of the safety and efficacy of transcranial direct current stimulation at higher current intensities for healthy subjects and people with Multiple Sclerosis.
Despite some work on the feasibility and safety of performing tDCS at intensities > 2 mA (i.e., up to 4 mA), the convention for most tDCS studies is to use intensities less than or equal to 2 mA. This has been sufficient to illicit measurable effects in both excitability and performance outcomes. However, the potential benefits of increasing intensity to either enhance the effects of a given stimulation protocol (e.g., time or magnitude) or to potentially access deeper brain areas justifies further exploration of current intensities > 2 mA. It is also important to add to the safety protocol of higher intensities in healthy and clinical (e.g., PwMS) subjects. The investigators hypothesize that higher intensities (i.e., > 2 mA) will be well tolerated by both healthy subjects and PwMS. Additionally, the investigators hypothesize no serious adverse effects from higher stimulation intensities. The existing side-effects of tDCS at intensities less than or equal to 2 mA include low-grade occurrences of tingling, itching, and burning sensation at the electrode sites; a few subjects have reported short-lived (< 5 min) headaches. In a study testing the safety of higher intensities similar to those proposed here, these same side-effects were observed in 50% of the subjects. This rate of occurrence is slightly higher than studies using less than or equal to 2 mA, but the magnitudes of the negative effects were still well within safely tolerable limits and were all transient in nature.
I.6 Background and significance and/or Preliminary studies related to this project.
(do not indicate "see protocol") Transcranial direct current stimulation (tDCS) is a non-invasive and well-tolerated brain stimulation technique (1-4) that can modulate the cortical excitability of targeted brain regions (5) as well as cerebral blood flow (6) in a polarity-dependent manner.
Models of tDCS current flow (7,8) and findings from studies in which human functional magnetic resonance Imaging (fMRI) has been used to measure brain activity (9-11) suggest that tDCS can alter processing across large areas of the cortex. In this sense, the effects of tDCS are likely to be relatively broad. Thus, while the neural changes induced by tDCS are concentrated around regions of cortex closest to the electrodes (12), broader networks of functionally-connected regions may also be recruited (9,10,13,14). Furthermore, no systematic investigation has been done to determine the most efficacious current intensity for PwMS.
There is empirical evidence that tDCS with current intensity between 1 and 2 mA for 20-40 minutes for either single or multiple sessions can safely and effectively be administered to PwMS (15-20). Although tDCS with current intensities > 2 mA are considered safe 21, no studies have investigated how brain activity is affected during tDCS at intensities > 2 mA. Although the safety of higher intensity tDCS in PwMS may be initially assumed from previous work using subjects who have experienced a stroke (21), it has also been suggested that more studies on the safety of higher intensity stimulation in other populations are needed in order to exercise due diligence before widely prescribing intensities greater than the present convention (22).
The cerebral activation in PwMS has been investigated with [15O] water and with [15O] O2 PET (indexes oxygen metabolism)(23). Widespread reductions in cerebral blood flow and oxygen metabolism in both gray and white mater have been reported in PwMS (24). Furthermore, these studies indicate that the degree of oxygen metabolism reduction correlated with worse cognitive performance and expanded disability status scale (EDSS), and that the degree of cerebral oxygen hypometabolism was associated with the number of relapses (25).
A close coupling of perfusion and metabolism is assumed, reflecting oxidative phosphorylation of glucose as the predominant source of energy production. Consequently, CBF is often considered as an indirect measure of neuronal function and integrity (26). This is supported by the significant association of metabolism with regional CBF (rCBF) across different brain regions (27,28), and with global CBF (gCBF) across varying states of consciousness (29).
With this study, the investigators will be able to substantiate if rCBF is affected by tDCS, assess the amount of signal change in relation to different currents, and measure differences in CBF distribution under stimulation reactivity between healthy subjects and PwMS. The objective is to investigate the changes in rCBF after transcranial direct current stimulation at different intensities (1 mA, 2 mA, 3 mA, 4 mA) in healthy subjects and PwMS. The design is a cross-sectional proof of principle study in 10 healthy subjects and 10 PwMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- People with Multiple Sclerosis and healthy controls will receive tDCS at different intensities while in the PET scanner.
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | Experimental | Device: tDCSPeople with MS get tDCS with different intensities. |
| Healthy Subjects | Active comparator | Device: tDCSHealthy subjects get tDCS with different intensities. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of multiple sclerosis by a neurologist
- No change in MS-specific medication (disease modification drugs) in the last three months
- Healthy enough to complete the protocol based on information obtained from a clinical exam and past medical history.
- An expanded disability status scale (EDSS) below 5.5
- Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
Key exclusion criteria (16 listed)
- A relapse of disease symptoms in the last three months
- History / presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
- Alcohol dependence or abuse (>2 drinks/day), or present history (last six months) of drug abuse
- History of significant traumatic brain injury or hydrocephalus
- Currently pregnant
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 |
|---|---|---|
| tDCSSubjects will get tDCS at intensities of 0, 1, 2, 3, and 4 mA. | Device | Healthy Subjects, Multiple Sclerosis |
Primary outcome
Cerebral Blood Flow
Time frame: Through study completion, an average of 1 year
Cerebral Blood flow will be measured while subjects undergo tDCS at different intensities in the PET scanner.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
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 tDCS 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 8 inclusion and 16 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 28 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebral Blood Flow (time frame: Through study completion, an average of 1 year). 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 28 Sep 2021.