HealthyfMRINCT05436249
Use of Real-Time Functional Magnetic Resonance Imaging Neurofeedback to Improve Motor Function in Cerebellar Ataxia
A study testing Neurofeedback treatment and At-home therapy in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This project will study the feasibility of motor rehabilitation in people with cerebellar ataxia using real-time functional magnetic resonance imaging neurofeedback (rt-fMRI NF) in conjunction with motor imagery. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neurofeedback treatment and At-home therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2022to 15 Jan 2024
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-100 years of age
- At least 8th-grade education
- Right-handedness
Who cannot join
- History of Axis I psychiatric disorders (including alcohol and drug dependence)
- Severe or unstable medical disorder, neurological disorders, such as stroke or epilepsy
- History of head injury that resulted in a loss of consciousness greater than 5 minutes and/or neurological sequelae
- Any condition that is contraindicated for the MRI environment (e.g., metal in the body, pacemaker, claustrophobia)
- Currently pregnant
- Eligible subjects may be asked to refrain from medications that affect the central nervous system that would also make data difficult to interpret (e.g., sedatives) for an appropriate period of time prior to scanning
- Participants will be excluded if they do not have a home computer with internet available to complete the 3-week at-home component of the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Using Motor Imagery and Machine Learning-Based Real-Time fMRI Neurofeedback to Improve Motor Function in Cerebellar Ataxia
This project will study the feasibility of motor rehabilitation in people with cerebellar ataxia using real-time functional magnetic resonance imaging neurofeedback (rt-fMRI NF) in conjunction with motor imagery. To do so, data will be collected from healthy adults in this protocol, to be compared with data from cerebellar ataxia participants.
- Conditions
- Healthy
- Being tested
- Neurofeedback treatment, At-home therapy
- Keywords
- Cerebellar Ataxia, Healthy Controls, Ataxia, Spinocerebellar Ataxias, Cerebellar Diseases, Neurodegenerative Diseases, Movement Disorders, Cerebellum, Gait, Balance
- Medical subject headings
- Cerebellar Ataxia, Ataxia, Spinocerebellar Ataxias, Cerebellar Diseases, Neurodegenerative Diseases, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback treatmentDevice
During the fMRI scan, the tasks consist of:
- Overt finger tapping in time with a flashing cue.
- Motor imagery (of finger tapping).
During overt finger tapping, feedback will consist of a slider bar that indicates tapping accuracy to target speed (1 or 4Hz). During motor imagery, neurofeedback will consist of a slider bar that indicates the success of recruiting predicted brain regions (consistent with those engaged during overt tapping).
At-home therapyBehavioural
Participants are assigned to groups where they will practice each day for 3 weeks at-home.
- Group 1: Imagery only.
- Group 2: Overt finger tapping only.
- Group 3: Imagery plus overt finger tapping.
During imagery, participants will view the task while imagining that they are finger tapping in time with the flashing cue, using the imagery strategies identified during their previous neurofeedback session. During overt tapping, participants will finger tap in time with the flashing cue. A final assessment of overt tapping will be performed the day after therapy ends.
| Study group | Role | What they receive |
|---|---|---|
| Real time neurofeedback with task | Other | Participants will undergo a real-time fMRI scan during which two distinct tasks will be performed. Receives: Device: Neurofeedback treatment |
| Overt tapping and/or motor imagery practice | Other | Participants will undergo an overt tapping task at baseline. Participants are assigned to a group where they will then perform respective motor and/or imagery tasks at home for 3 weeks. Receives: Behavioral: At-home therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed
During the MRI session, accuracy on overt tapping will be measured by the distance of the actual tapping rate vs. target rate (1Hz). Accuracy at baseline will be compared to that of final assessment, which will take place before and after neurofeedback training, respectively. The difference in accuracy between the two tests create a delta measure (i.e., fewer errors in the final vs. baseline tests). This delta accuracy will indicate the magnitude of tapping accuracy improvements. Root mean squared error (RMSE) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 1 tap for 1Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
Measured: Baseline and MRI duration, up to 1 hour
Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 4Hz speed
During the MRI session, accuracy on overt tapping will be measured by the distance of the actual tapping rate vs. target rate (4Hz). Accuracy at baseline will be compared to that of final assessment, which will take place before and after neurofeedback training, respectively. The difference in accuracy between the two tests create a delta measure (i.e., fewer errors in the final vs. baseline tests). This delta accuracy will indicate the magnitude of tapping accuracy improvements. RMSE (root mean squared error) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 4 taps for 4Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
Measured: Baseline and MRI duration, up to 1 hour
Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed
Accuracy at baseline will be compared to that of final assessment, which will take place before and after the 3-week at-home practice sessions, respectively. The delta measure will indicate the magnitude of tapping accuracy improvements. Groups will be compared to examine differences in delta as a function of practice condition (imagery only, tapping only, or imagery plus tapping). At-home tapping performance will be compared to MRI tapping performance. RMSE (root mean squared error) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 1 tap for 1Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
Measured: Baseline and At-home sessions (10 minutes/day), up to 23 days
Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 4Hz speed
Accuracy at baseline will be compared to that of final assessment, which will take place before and after the 3-week at-home practice sessions, respectively. The delta measure will indicate the magnitude of tapping accuracy improvements. Groups will be compared to examine differences in delta as a function of practice condition (imagery only, tapping only, or imagery plus tapping). At-home tapping performance will be compared to MRI tapping performance. RMSE (root mean squared error) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 4 taps for 4Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
Measured: Baseline and At-home sessions (10 minutes/day), up to 23 days
Secondary outcomes (4)
The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 1Hz as assessed by a correlation coefficient
This will assess the correlation between MRI Blood Oxygen Level Dependence (BOLD) and finger tapping accuracy by a correlation coefficient. The correlation coefficient ranges from -1 to 1, where the closer the coefficient is to -1 indicates a strong negative association and the closer the coefficient is to 1 indicates a strong positive association.
Measured: MRI duration, up to 1 hour
The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 4Hz as assessed by a correlation coefficient
This will assess the correlation between MRI BOLD (Blood Oxygen Level Dependence) and finger tapping accuracy by a correlation coefficient. The correlation coefficient ranging from -1 to 1, where the closer the coefficient is to -1 indicates a negative association and the closer the coefficient is to 1 indicates a strong positive association.
Measured: MRI duration, up to 1 hour
The correlation between the KVIQ and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient
The Kinesthetic and Visual Imagery Questionnaire (KVIQ), overall score ranging from 0-100, where higher scores reflect more vivid imagery) will assess imagery vividness. This will be correlated with the image accuracy measures described in Secondary Outcome Measure 5'.
Measured: Up to 1.5 hours
The correlation between the ICARS and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient
The International Cooperative Ataxia Rating Scale (ICARS), overall score ranging from 0-100, where higher scores indicate more severe neurological impairment) will assess neurological impairments. This will be correlated with image accuracy measures described in 'Secondary Outcome Measure 5'.
Measured: Up to 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start7 Dec 2022
- Primary completion28 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, Johns Hopkins Discovery Award
- Responsible party
- Sponsor
- Investigators
- Cherie Marvel, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436249
- Sponsor's protocol ID
- IRB00281329
- Acronym
- fMRI
- Status last verified
- Apr 2024
- First submitted
- 23 Jun 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Motor Imagery and Machine Learning-Based Real-Time fMRI Neurofeedback to Improve Motor Function in Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT05436249
- Acronym / sponsor ID
- fMRI / IRB00281329
- Conditions
- Healthy
- Keywords
- Cerebellar Ataxia, Healthy Controls, Ataxia, Spinocerebellar Ataxias, Cerebellar Diseases, Neurodegenerative Diseases, Movement Disorders, Cerebellum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, Johns Hopkins Discovery Award
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 29 Jun 2022 (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.
This project will study the feasibility of motor rehabilitation in people with cerebellar ataxia using real-time functional magnetic resonance imaging neurofeedback (rt-fMRI NF) in conjunction with motor imagery. To do so, data will be collected from healthy adults in this protocol, to be compared with data from cerebellar ataxia participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real time neurofeedback with task | Other | Device: Neurofeedback treatmentParticipants will undergo a real-time fMRI scan during which two distinct tasks will be performed. |
| Overt tapping and/or motor imagery practice | Other | Behavioral: At-home therapyParticipants will undergo an overt tapping task at baseline. Participants are assigned to a group where they will then perform respective motor and/or imagery tasks at home for 3 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-100 years of age
- At least 8th-grade education
- Right-handedness
Key exclusion criteria (7 listed)
- History of Axis I psychiatric disorders (including alcohol and drug dependence)
- Severe or unstable medical disorder, neurological disorders, such as stroke or epilepsy
- History of head injury that resulted in a loss of consciousness greater than 5 minutes and/or neurological sequelae
- Any condition that is contraindicated for the MRI environment (e.g., metal in the body, pacemaker, claustrophobia)
- 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 |
|---|---|---|
| Neurofeedback treatmentDuring the fMRI scan, the tasks consist of: 1. Overt finger tapping in time with a flashing cue. 2. Motor imagery (of finger tapping). During overt finger tapping, feedback will consist of a slider bar that indicates tapping accuracy to target speed (1 or 4Hz). During motor imagery, neurofeedback will consist of a slider bar that indicates the success of recruiting predicted brain regions (consistent with those engaged during overt tapping). | Device | Real time neurofeedback with task |
| At-home therapyParticipants are assigned to groups where they will practice each day for 3 weeks at-home. 1. Group 1: Imagery only. 2. Group 2: Overt finger tapping only. 3. Group 3: Imagery plus overt finger tapping. During imagery, participants will view the task while imagining that they are finger tapping in time with the flashing cue, using the imagery strategies identified during their previous neurofeedback session. During overt tapping, participants will finger tap in time with the flashing cue. A final assessment of overt tapping will be performed the day after therapy ends. | Behavioural | Overt tapping and/or motor imagery practice |
Primary outcome
Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed
Time frame: Baseline and MRI duration, up to 1 hour
During the MRI session, accuracy on overt tapping will be measured by the distance of the actual tapping rate vs. target rate (1Hz). Accuracy at baseline will be compared to that of final assessment, which will take place before and after neurofeedback training, respectively. The difference in accuracy between the two tests create a delta measure (i.e., fewer errors in the final vs. baseline tests). This delta accuracy will indicate the magnitude of tapping accuracy improvements. Root mean squared error (RMSE) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 1 tap for 1Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 4Hz speed
Time frame: Baseline and MRI duration, up to 1 hour
During the MRI session, accuracy on overt tapping will be measured by the distance of the actual tapping rate vs. target rate (4Hz). Accuracy at baseline will be compared to that of final assessment, which will take place before and after neurofeedback training, respectively. The difference in accuracy between the two tests create a delta measure (i.e., fewer errors in the final vs. baseline tests). This delta accuracy will indicate the magnitude of tapping accuracy improvements. RMSE (root mean squared error) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 4 taps for 4Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed
Time frame: Baseline and At-home sessions (10 minutes/day), up to 23 days
Accuracy at baseline will be compared to that of final assessment, which will take place before and after the 3-week at-home practice sessions, respectively. The delta measure will indicate the magnitude of tapping accuracy improvements. Groups will be compared to examine differences in delta as a function of practice condition (imagery only, tapping only, or imagery plus tapping). At-home tapping performance will be compared to MRI tapping performance. RMSE (root mean squared error) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 1 tap for 1Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 4Hz speed
Time frame: Baseline and At-home sessions (10 minutes/day), up to 23 days
Accuracy at baseline will be compared to that of final assessment, which will take place before and after the 3-week at-home practice sessions, respectively. The delta measure will indicate the magnitude of tapping accuracy improvements. Groups will be compared to examine differences in delta as a function of practice condition (imagery only, tapping only, or imagery plus tapping). At-home tapping performance will be compared to MRI tapping performance. RMSE (root mean squared error) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will be based on the actual number of taps per second relative to the expected number of taps per second (e.g., 4 taps for 4Hz). Then post treatment RMSE minus baseline RMSE will determine a delta RMSE. A higher RMSE signifies greater error. For the delta measure, it is expected, lower scores reflect greater improvement on the task.
4 secondary outcomes
The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 1Hz as assessed by a correlation coefficient
Time frame: MRI duration, up to 1 hour
The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 4Hz as assessed by a correlation coefficient
Time frame: MRI duration, up to 1 hour
The correlation between the KVIQ and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient
Time frame: Up to 1.5 hours
The correlation between the ICARS and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient
Time frame: Up to 1.5 hours
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 5 Apr 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Cherie Marvel, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback treatment and At-home therapy in people with Healthy, run by Johns Hopkins University 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 7 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 5 Apr 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?
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?
Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed (time frame: Baseline and MRI duration, up to 1 hour). 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 5 Apr 2024.