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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05436249
Other study ID # IRB00281329
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2022
Est. completion date January 15, 2024

Study information

Verified date April 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 15, 2024
Est. primary completion date December 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
United States Johns Hopkins University School of Medicine Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University Johns Hopkins Discovery Award, Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and MRI duration, up to 1 hour
Primary 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. Baseline and MRI duration, up to 1 hour
Primary 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. Baseline and At-home sessions (10 minutes/day), up to 23 days
Primary 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. Baseline and At-home sessions (10 minutes/day), up to 23 days
Secondary 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. MRI duration, up to 1 hour
Secondary 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. MRI duration, up to 1 hour
Secondary 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'. Up to 1.5 hours
Secondary 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'. Up to 1.5 hours
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