fMRI: Use of Real-Time Functional Magnetic Resonance Imaging Neurofeedback to Improve Motor Function in Cerebellar Ataxia

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05436249

Collaborator

Virginia Polytechnic Institute and State University (Other), Johns Hopkins Discovery Award (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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. To do so, data will be collected from healthy adults in this protocol, to be compared with data from cerebellar ataxia participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Neurofeedback treatment Behavioral: At-home therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Using Motor Imagery and Machine Learning-Based Real-Time fMRI Neurofeedback to Improve Motor Function in Cerebellar Ataxia

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Real time neurofeedback with task Participants will undergo a real-time fMRI scan during which two distinct tasks will be performed.	Device: Neurofeedback treatment 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).
Other: Overt tapping and/or motor imagery practice 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.	Behavioral: At-home therapy 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.

Arm

Intervention/Treatment

Other: Real time neurofeedback with task

Participants will undergo a real-time fMRI scan during which two distinct tasks will be performed.

Device: Neurofeedback treatment

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).

Other: Overt tapping and/or motor imagery practice

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.

Behavioral: At-home therapy

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.

Outcome Measures

Primary Outcome Measures

Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed [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 [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 [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 [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.

Secondary Outcome Measures

The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 1Hz as assessed by a correlation coefficient [MRI duration, up to 1 hour]
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.
The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 4Hz as assessed by a correlation coefficient [MRI duration, up to 1 hour]
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.
The correlation between the KVIQ and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient [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 between the ICARS and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient [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'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-100 years of age
At least 8th-grade education
Right-handedness

Exclusion Criteria:

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