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

NCT05436249 | Completed

• 1 other identifier: IRB00281329
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cerebellar Ataxia; Healthy Controls; Ataxia; Spinocerebellar Ataxias; Cerebellar Diseases; Neurodegenerative Diseases; Movement Disorders; Cerebellum; Gait; Balance

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• 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

• 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

• 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 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

Study Arms (2)

Real time neurofeedback with task

OTHER

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

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.

Behavioral: At-home therapy

Interventions

Neurofeedback treatment DEVICE

During 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).

Real time neurofeedback with task

At-home therapy BEHAVIORAL

Participants 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.

Overt tapping and/or motor imagery practice

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Virginia Polytechnic Institute and State University: collaborator
• Johns Hopkins Discovery Award: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Cerebellar Ataxia; Ataxia; Spinocerebellar Ataxias; Cerebellar Diseases; Neurodegenerative Diseases; Movement Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cherie Marvel, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: December 7, 2022
• Primary Completion: December 28, 2023
• Study Completion: January 15, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact cmarvel1@jhmi.edu.

Locations

US (1)