Multiple SclerosisNCT03564496
Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
A study testing tDCS Administration during MRI, Remotely-supervised Daily tDCS Administration and Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- tDCS Administration during MRI, Remotely-supervised Daily tDCS Administration and Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 29 Sep 2021
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be 18 years of age or older
- Standardized SDMT Z-score > - 3.0
- Fatigue Severity Scale score > 36
- Definite MS diagnosis as assessed by licensed physician any subtype including Relapsing Remitting (RRMS), Primary Progressive (PPMS) or Secondary Progressive (SPMS)
- Score of ≤ 7.0 on the Expanded Disability Status Scale
- Clinically stable without disease progression in the past 3 months
Show all 16Show fewer
- Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or Ethernet cable)
- Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/
- Adequate home facilities (enough space, access to quiet and distraction free area)
- Able to commit to the four-week period of training sessions with baseline and two follow-up visits
- Participants must be 18 years of age or older
- Standardized SDMT Z-score > - 3.0
- Have not been diagnosed with MS or other neurological disorder
- Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/ (HC subgroup only)
- Adequate home facilities including enough space, access to quiet and distraction free area (HC subgroup only)
- Able to commit to the four-week period of training sessions with baseline and one follow-up visit (HC subgroup only)
Who cannot join
- Extreme claustrophobia
- Relapse or steroid use in previous month
- History of mental retardation, pervasive developmental disorder, or other neurological condition associated with cognitive impairment
- Primary psychiatric disorder that would influence ability to participate
- Current uncontrolled seizure disorder
- Current substance abuse disorder
Show all 21Show fewer
- Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- Treatment for a communicable skin disorder currently or over the past 12 months
- Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
- Pregnant or breastfeeding
- Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition Scaled Score < 85
- Beck Depression Inventory - Fast Screen (BDI-FS) score > 9
- Extreme claustrophobia
- History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
- Primary psychiatric disorder that would influence ability to participate
- Current uncontrolled seizure disorder
- Current substance abuse disorder
- Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- Treatment for a communicable skin disorder currently or over the past 12 months
- Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation. Methodology for this study is the administration of 15-minutes of of active tDCS during MRI acquisition compared to time without active tDCS.
- Conditions
- Multiple Sclerosis
- Being tested
- tDCS Administration during MRI, Remotely-supervised Daily tDCS Administration, Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA
- Keywords
- Anodal transcranial stimulation (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.
tDCS Administration during MRIDevice
All participants including healthy controls and MS patients will be given approximately 15 minutes of active tDCS during MRI. The simultaneous tDCS will be performed up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on to when the tDCS is off. The stimulation consists of 15-min up to 2 mA tDCS using 5x5 cm electrode sponges with ~30s ramp-up and ramp-down periods.
Remotely-supervised Daily tDCS AdministrationDevice
While the first tDCS session will be performed at clinic under the full supervision, remaining sessions 2-20 (~ 1 month) will be completed at home with remote monitoring by the study technician. Participants in the HC subgroup who opt-in to the additional 15 minutes of imaging +tDCS may complete the first session remotely.
For at-home tDCS administration, participants will be given the specially-designed tDCS device and headset, study laptop computer for secure video monitoring with study technician (must have internet access) and access to the cognitive training program, a detailed reference manual, and a training video. The device will produce up to 2.0 mA stimulation for around 20 minutes, and will not operate without the correct headset placement. The device will also automatically abort the session if optimal conditions are not maintained. It reports and records a completion code for each session.
Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mADevice
Participants in the healthy control subgroup who are willing may have an additional 15 minutes of imaging combined with 10 minutes of simultaneous tDCS of up to 4.0mA added at the end of their baseline scan. In this case, after the initial imaging and tDCS portion is complete, the participant will remain on the scanner for an additional 15 minutes during which brain imaging will continue and will be combined with 10 minutes of simultaneous tDCS up to 4.0mA. This will be a one-time add-on and will not be required at follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Active comparator | Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Receives: Device: tDCS Administration during MRI |
| MS Patients | Experimental | MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments. Receives: Device: tDCS Administration during MRI; Device: Remotely-supervised Daily tDCS Administration |
| Healthy Control subgroup | Active comparator | The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Receives: Device: tDCS Administration during MRI; Device: Remotely-supervised Daily tDCS Administration; Device: Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Metabolic Rate of Oxygen (CMRO2)
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Measured: Baseline Visit
Cerebral Metabolic Rate of Oxygen (CMRO2)
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Measured: Intermediate Visit (Month 1)
Neuronal Reactivity (NR)
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS. tDCS will be administered in one visit and will last for approximately 15 minutes.
Measured: Baseline Visit (pre-tDCS, post-tDCS)
Neuronal Reactivity (NR)
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS.
Measured: Baseline, Intermediate Visit (Month 1)
Secondary outcomes (3)
Quality of Life in Neurological Disorders (Neuro-QOL) Score
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
Measured: Baseline Visit
Quality of Life in Neurological Disorders (Neuro-QOL) Score
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
Measured: Intermediate Visit (Month 1)
Quality of Life in Neurological Disorders (Neuro-QOL) Score
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
Measured: Final Visit (Month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start9 Jul 2018
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
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 NYU Langone HealthThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564496
- Sponsor's protocol ID
- 18-00548
- Status last verified
- Dec 2023
- First submitted
- 11 Jun 2018
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data collection will be for pilot data and exploratory analysis.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
- ClinicalTrials.gov ID
- NCT03564496
- Acronym / sponsor ID
- 18-00548
- Conditions
- Multiple Sclerosis
- Keywords
- Anodal transcranial stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Posted 17 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation. Methodology for this study is the administration of 15-minutes of of active tDCS during MRI acquisition compared to time without active tDCS.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation.
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Active comparator | Device: tDCS Administration during MRIHealthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit. |
| MS Patients | Experimental | Device: tDCS Administration during MRI, Device: Remotely-supervised Daily tDCS AdministrationMS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments. |
| Healthy Control subgroup | Active comparator | Device: tDCS Administration during MRI, Device: Remotely-supervised Daily tDCS Administration, Device: Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mAThe Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants must be 18 years of age or older
- Standardized SDMT Z-score > - 3.0
- Fatigue Severity Scale score > 36
- Definite MS diagnosis as assessed by licensed physician any subtype including Relapsing Remitting (RRMS), Primary Progressive (PPMS) or Secondary Progressive (SPMS)
- Score of ≤ 7.0 on the Expanded Disability Status Scale
Key exclusion criteria (21 listed)
- Extreme claustrophobia
- Relapse or steroid use in previous month
- History of mental retardation, pervasive developmental disorder, or other neurological condition associated with cognitive impairment
- Primary psychiatric disorder that would influence ability to participate
- Current uncontrolled seizure disorder
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 |
|---|---|---|
| tDCS Administration during MRIAll participants including healthy controls and MS patients will be given approximately 15 minutes of active tDCS during MRI. The simultaneous tDCS will be performed up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on to when the tDCS is off. The stimulation consists of 15-min up to 2 mA tDCS using 5x5 cm electrode sponges with ~30s ramp-up and ramp-down periods. | Device | Healthy Control subgroup, Healthy Controls, MS Patients |
| Remotely-supervised Daily tDCS AdministrationWhile the first tDCS session will be performed at clinic under the full supervision, remaining sessions 2-20 (~ 1 month) will be completed at home with remote monitoring by the study technician. Participants in the HC subgroup who opt-in to the additional 15 minutes of imaging +tDCS may complete the first session remotely. For at-home tDCS administration, participants will be given the specially-designed tDCS device and headset, study laptop computer for secure video monitoring with study technician (must have internet access) and access to the cognitive training program, a detailed reference manual, and a training video. The device will produce up to 2.0 mA stimulation for around 20 minutes, and will not operate without the correct headset placement. The device will also automatically abort the session if optimal conditions are not maintained. It reports and records a completion code for each session. | Device | Healthy Control subgroup, MS Patients |
| Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mAParticipants in the healthy control subgroup who are willing may have an additional 15 minutes of imaging combined with 10 minutes of simultaneous tDCS of up to 4.0mA added at the end of their baseline scan. In this case, after the initial imaging and tDCS portion is complete, the participant will remain on the scanner for an additional 15 minutes during which brain imaging will continue and will be combined with 10 minutes of simultaneous tDCS up to 4.0mA. This will be a one-time add-on and will not be required at follow-up. | Device | Healthy Control subgroup |
Primary outcome
Cerebral Metabolic Rate of Oxygen (CMRO2)
Time frame: Baseline Visit
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Cerebral Metabolic Rate of Oxygen (CMRO2)
Time frame: Intermediate Visit (Month 1)
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Neuronal Reactivity (NR)
Time frame: Baseline Visit (pre-tDCS, post-tDCS)
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS. tDCS will be administered in one visit and will last for approximately 15 minutes.
Neuronal Reactivity (NR)
Time frame: Baseline, Intermediate Visit (Month 1)
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS.
3 secondary outcomes
Quality of Life in Neurological Disorders (Neuro-QOL) Score
Time frame: Baseline Visit
Quality of Life in Neurological Disorders (Neuro-QOL) Score
Time frame: Intermediate Visit (Month 1)
Quality of Life in Neurological Disorders (Neuro-QOL) Score
Time frame: Final Visit (Month 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data collection will be for pilot data and exploratory analysis.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
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.
Leigh Charvet, MD principal investigator
NYU Langone Health
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 Administration during MRI, Remotely-supervised Daily tDCS Administration and Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA in people with Multiple Sclerosis, run by NYU Langone Health 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 16 inclusion and 21 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 17 Jan 2024. 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 17 Jan 2024). 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?
Cerebral Metabolic Rate of Oxygen (CMRO2) (time frame: Baseline Visit). The study lists 4 primary outcomes in all. 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 17 Jan 2024.