Multiple SclerosisNCT04466228
Non-invasive Transcranial Electrical Stimulation in MS
A study testing non-invasive transcranial electrical stimulation in people with Multiple Sclerosis and Cognitive Impairment, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Impairment
- What is being tested?
- non-invasive transcranial electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 23 Aug 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65,
- diagnosis of MS
- Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs
- a minimum of 3 months since the last relapse
- Beck Depression Inventory<19
- normal hearing
- and no changes in MS or symptomatic medications in past 2 months
Who cannot join
- prior brain surgery
- clips in brain
- epilepsy or other neurological or non-affective psychiatric disorders
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Sandler Neurosciences Center
San Francisco, California, 94158
About this study
Official title: Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis
The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.
Read the detailed description
The participants' baseline cognitive function will be assessed with a tablet-based, videogame-like software specifically designed as a medical device to test and train cognitive function for populations with cognitive disorders. After baseline test assessment, participants will receive stimulation while playing the training version of the software. After the stimulation, cognitive performance will be evaluated again with the testing version. Investigators will assess changes in cognitive performance associated with stimulation.
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Being tested
- non-invasive transcranial electrical stimulation
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive transcranial electrical stimulationDevice
Non-invasive transcranial electrical stimulation across the prefrontal cortex.
| Study group | Role | What they receive |
|---|---|---|
| Stim1 high dose | Experimental | This group will receive high dose non-invasive transcranial electrical stimulation Receives: Device: non-invasive transcranial electrical stimulation |
| Stim2 low dose | Experimental | This group will receive low dose non-invasive transcranial electrical stimulation Receives: Device: non-invasive transcranial electrical stimulation |
| Sham control | Sham comparator | This group will receive sham control non-invasive transcranial electrical stimulation Receives: Device: non-invasive transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Processing Speed Change From Baseline Assessment
Symbol Digit Modalities Test (SDMT) score will be used to measure processing speed. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.
Measured: Baseline (pre-stim) and post-stimulation (up to 2 hours)
EVO Performance Change From Baseline Assessment
EVO tool is a digital cognitive assessment developed to assess cognitive function including attention and related cognitive control processes in clinical populations. It comes with the closed-loop adaptive algorithm which makes proportional changes in gameplay difficulty when the participant's performance deviates from an 80% rate of accuracy, which ensures that task difficulty is equated across participants and enhances engagement. Gameplay threshold (level 0 to level 20), response time and response time variability will be measured to evaluate attention control. Higher threshold level, lower response time and smaller response time variability indicate improvement.
Measured: Baseline (pre-stim) and post-stimulation, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start16 Oct 2020
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466228
- Sponsor's protocol ID
- FG-1908-34831
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2020
- Last updated
- 4 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hsu WY, Zanto T, Park JE, Gazzaley A, Bove RM. Effects of transcranial alternating current stimulation on cognitive function in people with multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2023 Dec;80:105090. doi: 10.1016/j.msard.2023.105090. Epub 2023 Oct 19.
PubMed 37925960
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04466228
- Acronym / sponsor ID
- FG-1908-34831
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Posted 4 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.
Detailed description
The participants' baseline cognitive function will be assessed with a tablet-based, videogame-like software specifically designed as a medical device to test and train cognitive function for populations with cognitive disorders. After baseline test assessment, participants will receive stimulation while playing the training version of the software. After the stimulation, cognitive performance will be evaluated again with the testing version. Investigators will assess changes in cognitive performance associated with stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stim1 high dose | Experimental | Device: non-invasive transcranial electrical stimulationThis group will receive high dose non-invasive transcranial electrical stimulation |
| Stim2 low dose | Experimental | Device: non-invasive transcranial electrical stimulationThis group will receive low dose non-invasive transcranial electrical stimulation |
| Sham control | Sham comparator | Device: non-invasive transcranial electrical stimulationThis group will receive sham control non-invasive transcranial electrical stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-65,
- diagnosis of MS
- Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs
- a minimum of 3 months since the last relapse
- Beck Depression Inventory<19
Key exclusion criteria (4 listed)
- prior brain surgery
- clips in brain
- epilepsy or other neurological or non-affective psychiatric disorders
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive transcranial electrical stimulationNon-invasive transcranial electrical stimulation across the prefrontal cortex. | Device | Sham control, Stim1 high dose, Stim2 low dose |
Primary outcome
Processing Speed Change From Baseline Assessment
Time frame: Baseline (pre-stim) and post-stimulation (up to 2 hours)
Symbol Digit Modalities Test (SDMT) score will be used to measure processing speed. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.
EVO Performance Change From Baseline Assessment
Time frame: Baseline (pre-stim) and post-stimulation, up to 2 hours
EVO tool is a digital cognitive assessment developed to assess cognitive function including attention and related cognitive control processes in clinical populations. It comes with the closed-loop adaptive algorithm which makes proportional changes in gameplay difficulty when the participant's performance deviates from an 80% rate of accuracy, which ensures that task difficulty is equated across participants and enhances engagement. Gameplay threshold (level 0 to level 20), response time and response time variability will be measured to evaluate attention control. Higher threshold level, lower response time and smaller response time variability indicate improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37925960Hsu WY, Zanto T, Park JE, Gazzaley A, Bove RM. Effects of transcranial alternating current stimulation on cognitive function in people with multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2023 Dec;80:105090. doi: 10.1016/j.msard.2023.105090. Epub 2023 Oct 19.
- 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.
Riley Bove, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive transcranial electrical stimulation in people with Multiple Sclerosis and Cognitive Impairment, run by University of California, San Francisco 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 7 inclusion and 4 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 4 Dec 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. Some participants in this study may receive a placebo. 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 4 Dec 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?
Processing Speed Change From Baseline Assessment (time frame: Baseline (pre-stim) and post-stimulation (up to 2 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04466228, which also lists 1 linked publication.
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 4 Dec 2023.