StrokeNCT06384495
How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?
A study testing REAL-A and REAL-C in people with Stroke, run by University of Minnesota at 1 site in United States.
Trial summary
Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- REAL-A and REAL-C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 10 Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants must be over the age of 18 years of age
- must be fluent in English
- have adequate vision to see a computer screen from 12-18 inches, fine motor skills to press a key on a computer keyboard and hearing to hear directions and questions provided by the researcher
- Individuals must also be able to read words and phrases
Who cannot join
- Pregnancy
- history of seizures
- neurologic injury including concussion/head injury or stroke or other neurologic conditions
- History of documented learning disabilities and/or ADHD
- Metal implants in the body (excluding dental fillings), psoriasis or eczema affecting the scalp.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population.
Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity.
Read more
The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point.
Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface.
- Conditions
- Stroke
- Being tested
- REAL-A, REAL-C, SHAM
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REAL-AProcedure or surgery
one session of 2mA for 20 minutes to the right ventro-lateral cerebellum
REAL-CProcedure or surgery
one session of 2mA for 20 minutes to the right ventro-lateral cerebellum
SHAMProcedure or surgery
one session of sham tDCS for 20 minutes to the right ventro-lateral cerebellum.
| Study group | Role | What they receive |
|---|---|---|
| Real anodal tDCS group (REAL-A) | Experimental | Participants randomized to REAL-A Receives: Procedure: REAL-A |
| Real cathodal tDCS group (REAL-C) | Experimental | Participants randomized to REAL-C Receives: Procedure: REAL-C |
| Sham group (SHAM) | Sham comparator | Participants randomized to SHAM group Receives: Procedure: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
stimulus/response curve (S/R Curve)
change of motor evoked potential (MEP) as reflected in EMG from 1) hand (FDI muscle) and 2) mouth (orbicularis oris muscle).following single pulse transcranial magnetic stimulation (TMS) to the primary motor cortex of varying intensities.
Measured: baseline, 15,45 and 75 minutes post-tDCS
Cortical Silent Period (CSP)
Change in silent period of a contracted muscle shown through EMG from 1) hand (FDI muscle) and 2) mouth (orbicularis oris muscle). following a single supra-threshold stimulus pulse to the primary motor cortex using TMS.
Measured: baseline, 15,45 and 75 minutes post-tDCS
Short-interval Intracortical Inhibition (SICI).
Change in MEP as reflected in EMG from 1) hand (FDI muscle) and 2) mouth (orbicularis oris muscle). following a subthreshold conditioning pulse followed by a suprathreshold test pulse
Measured: baseline, 15,45 and 75 minutes post-tDCS
Secondary outcomes (3)
Digit Symbol Substitution Test (DSST)
The DSST is a 90-second timed test that evaluates processing speed, working memory, visuospatial processing, and attention. The test involves a subject replacing given numerals (1-9) with the corresponding unique, simple to draw, symbols provided in the key. The subject is instructed to write as many substitutions as possible within the allotted time. The score is determined by counting the correct number of substitutions. No penalty is applied for incorrect answers. The test permits freedom to achieve the task which allows for creativity and refinement to improve one's score. This test was originally a subsection of the Wechsler Adult Intelligence Test (WAIS), used to measure one's intelligence quotient (IQ)
Measured: baseline, 15, 45 and 75 minutes post stimulation
Serial Reaction Time Test (SRTT)
The SRTT is a four-choice reaction time task that measures motor learning. In this task, a visual cue can appear at any one of four positions arranged horizontally on a computer screen. Each screen position, designated 1-4, corresponds to a button on a response pad. When a cue appears, at the start of each trial, a participant selects the appropriate response button. The visual cues play out a repeating sequence of positions (for example, 2-3-1-4-3-2-4-1-3-4-2-1). Sequential trials are followed by random trials
Measured: baseline, 15, 45 and 75 minutes post stimulation
Lexical Decision Task
The lexical decision task requires the participant to make a decision whether a target letter string is a word or, with equal probability, a pronounceable non-word. The target string is preceded by a prime word that is either associated with the target word or, with equal probability, not associated
Measured: baseline, 15, 45 and 75 minutes post stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start15 Jul 2024
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Why it stopped: 1. The duration of research tasks exceeded the expected timeframe for uncompensated participants 2. The tDCS system was discontinued and therefore no longer serviced by the manufacturer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharyl Samargia-Grivette, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384495
- Sponsor's protocol ID
- STUDY00021475
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?
- ClinicalTrials.gov ID
- NCT06384495
- Acronym / sponsor ID
- STUDY00021475
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1. The duration of research tasks exceeded the expected timeframe for uncompensated participants 2. The tDCS system was discontinued and therefore no longer serviced by the manufacturer.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 25 Apr 2024 (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.
Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population.
Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity.
The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point.
Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real anodal tDCS group (REAL-A) | Experimental | Procedure: REAL-AParticipants randomized to REAL-A |
| Real cathodal tDCS group (REAL-C) | Experimental | Procedure: REAL-CParticipants randomized to REAL-C |
| Sham group (SHAM) | Sham comparator | Procedure: SHAMParticipants randomized to SHAM group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible participants must be over the age of 18 years of age
- must be fluent in English
- have adequate vision to see a computer screen from 12-18 inches, fine motor skills to press a key on a computer keyboard and hearing to hear directions and questions provided by the researcher
- Individuals must also be able to read words and phrases
Key exclusion criteria (5 listed)
- Pregnancy
- history of seizures
- neurologic injury including concussion/head injury or stroke or other neurologic conditions
- History of documented learning disabilities and/or ADHD
- Metal implants in the body (excluding dental fillings), psoriasis or eczema affecting the scalp.
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 |
|---|---|---|
| REAL-Aone session of 2mA for 20 minutes to the right ventro-lateral cerebellum | Procedure or surgery | Real anodal tDCS group (REAL-A) |
| REAL-Cone session of 2mA for 20 minutes to the right ventro-lateral cerebellum | Procedure or surgery | Real cathodal tDCS group (REAL-C) |
| SHAMone session of sham tDCS for 20 minutes to the right ventro-lateral cerebellum. | Procedure or surgery | Sham group (SHAM) |
Primary outcome
stimulus/response curve (S/R Curve)
Time frame: baseline, 15,45 and 75 minutes post-tDCS
change of motor evoked potential (MEP) as reflected in EMG from 1) hand (FDI muscle) and 2) mouth (orbicularis oris muscle).following single pulse transcranial magnetic stimulation (TMS) to the primary motor cortex of varying intensities.
Cortical Silent Period (CSP)
Time frame: baseline, 15,45 and 75 minutes post-tDCS
Change in silent period of a contracted muscle shown through EMG from 1) hand (FDI muscle) and 2) mouth (orbicularis oris muscle). following a single supra-threshold stimulus pulse to the primary motor cortex using TMS.
Short-interval Intracortical Inhibition (SICI).
Time frame: baseline, 15,45 and 75 minutes post-tDCS
Change in MEP as reflected in EMG from 1) hand (FDI muscle) and 2) mouth (orbicularis oris muscle). following a subthreshold conditioning pulse followed by a suprathreshold test pulse
3 secondary outcomes
Digit Symbol Substitution Test (DSST)
Time frame: baseline, 15, 45 and 75 minutes post stimulation
Serial Reaction Time Test (SRTT)
Time frame: baseline, 15, 45 and 75 minutes post stimulation
Lexical Decision Task
Time frame: baseline, 15, 45 and 75 minutes post stimulation
Results and safety
The study was stopped early (reason given: 1. The duration of research tasks exceeded the expected timeframe for uncompensated participants 2. The tDCS system was discontinued and therefore no longer serviced by the manufacturer.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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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.
Sharyl Samargia-Grivette principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAL-A and REAL-C in people with Stroke, run by University of Minnesota 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Aug 2025. 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?
The study was stopped early (reason given: 1. The duration of research tasks exceeded the expected timeframe for uncompensated participants 2. The tDCS system was discontinued and therefore no longer serviced by the manufacturer.). Results are not available in the source record.
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?
stimulus/response curve (S/R Curve) (time frame: baseline, 15,45 and 75 minutes post-tDCS). The study lists 3 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 24 Aug 2025.