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NCT05436262

Using Real-time fMRI Neurofeedback and Motor Imagery to Enhance Motor Timing and Precision in Cerebellar Ataxia

Completed NA Results posted Last updated 8 January 2025
What this trial tests

NA trial testing Real-time fMRI with neurofeedback of motor imagery in Cerebellar Ataxia in 21 participants. Completed in 22 January 2024.

Timeline
14 March 2023
Primary endpoint
22 January 2024
22 January 2024

Quick facts

Lead sponsorJohns Hopkins University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingnone
Primary purposebasic science
Enrollment21
Start date14 March 2023
Primary completion22 January 2024
Estimated completion22 January 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 100, any sex, with Cerebellar Ataxia or Spinocerebellar Ataxias. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 1Hz Speed Primary · 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

GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.00141488± .007294434
Change in Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 4Hz Speed Primary · 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. Root mean squared error (RMSE) is the measure for both the baseline and post-treatment behavioral tasks. RMSE will

GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.00165387± .010581808
Change in At-home Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 1Hz Speed Primary · 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 (tapping only or imagery plus tapping). 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 fo

GroupValue95% CI
Randomization: Homework Sessions With Tapping Only (Control Group).392919831± .6227685278
Randomization: Homework Sessions With Imagery Only (Intervention Group).200339199± .3242518927
Change in At-home Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 4Hz Speed Primary · 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 (tapping only or imagery plus tapping). 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 f

GroupValue95% CI
Randomization: Homework Sessions With Tapping Only (Control Group).35613192± .7481023854
Randomization: Homework Sessions With Imagery Only (Intervention Group).067492801± .5086197309
The Correlation Between MRI BOLD During Imagery and Finger Tapping Accuracy Improvements to a Flashing Cue at 1Hz as Assessed by a Correlation Coefficient Secondary · MRI duration, up to 1 hour

This will assess the correlation between MRI Blood Oxygen Level Dependence (BOLD) during imagery and finger tapping accuracy improvement (pre- vs. post- neurofeedback training) 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.

Left Crus II cerebellum
GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.850
Right Posterior Insula
GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.861
Right Inferior Frontal Gyrus
GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.838
Left Posterior Insula
GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.842
Left Internal Capsule
GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.884
Right Ventral Caudate
GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.850
The Correlation Between MRI BOLD and Finger Tapping Accuracy to a Flashing Cue at 4Hz as Assessed by a Correlation Coefficient Secondary · MRI duration, up to 1 hour

This will assess the correlation between MRI Blood Oxygen Level Dependence (BOLD) during imagery and finger tapping accuracy improvement (pre- vs. post- neurofeedback training) 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.

GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.688
The Correlation Between the KVIQ and Imagery Accuracy of the Flashing Cross on the MRI Task as Assessed by a Correlation Coefficient Secondary · Up to 1.5 hours

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. 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.

GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback.953
The Correlation Between the ICARS and Imagery Accuracy Accuracy of the Flashing Cross on the MRI Task as Assessed by a Correlation Coefficient Secondary · Up to 1.5 hours

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. 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.

GroupValue95% CI
Pre-Randomization: fMRI Neurofeedback-.263

Sponsor's own description

The aim of the research is to improve motor function in people with cerebellar ataxia by using neuroimaging methods and mental imagery to "exercise" motor networks in the brain. The relevance of this research to public health is that results have the potential to reduce motor deficits associated with cerebellar atrophy, thereby enhancing the quality of life and promoting independence.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Feasibility Study of Real-Time FMRI with Neurofeedback of Motor Performance in Cerebellar Ataxia
    Berenbaum J, Marvel C, Lisinski J, Soldate J, et al · · 2026

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Other recruiting trials for Cerebellar Ataxia

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05436262.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing