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

NCT05436262 | Completed Results

• 2 other identifiers: IRB00300264R21NS125546
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebellar Ataxia; Spinocerebellar Ataxias; Cerebellar Degeneration

Keywords

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

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. 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 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 (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 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 (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 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 During Imagery and Finger Tapping Accuracy Improvements 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 Flashing Cross on the MRI Task as Assessed by a Correlation Coefficient

  Up to 1.5 hours

• The Correlation Between the ICARS and Imagery Accuracy Accuracy of the Flashing Cross on the MRI Task as Assessed by a Correlation Coefficient

  Up to 1.5 hours

Study Arms (2)

Real time neurofeedback with task and at-home finger tapping practice sessions

EXPERIMENTAL

Participants will undergo a real-time fMRI scan during which two distinct tasks will be performed. Neurofeedback treatment: 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 crosshair that flashes to indicate the success of recruiting predicted brain regions (consistent with those engaged during overt tapping). At-home therapy: Participants are assigned to one of two groups where participants will practice each day 17 sessions total at-home. Group 1: Overt finger tapping on 17 daily sessions. Participants will finger tap in time with the flashing cue.

Device: Real-time fMRI with neurofeedback of motor imagery

Real time neurofeedback with task and at-home motor imagery practice sessions

EXPERIMENTAL

Participants will undergo a real-time fMRI scan during which two distinct tasks will be performed. Neurofeedback treatment: 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 crosshair that flashes to indicate the success of recruiting predicted brain regions (consistent with those engaged during overt tapping). At-home therapy: Participants are assigned to one of two groups where participants will practice each day 17 sessions total at-home. Group 2: Motor imagery only on 13 daily sessions, and overt finger tapping only on 4 daily sessions.

Device: Real-time fMRI with neurofeedback of motor imagery

Interventions

Real-time fMRI with neurofeedback of motor imagery DEVICE

Participants undergo a real-time fMRI scan during which they are provided feedback regarding the accuracy of their motor imagery performance.

Real time neurofeedback with task and at-home finger tapping practice sessions; Real time neurofeedback with task and at-home motor imagery practice sessions

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• At least 8th-grade education
• Right-handedness
• Clinical diagnosis of progressive, degenerative cerebellar ataxia by a movement disorder specialist (cerebellar ataxia of unknown etiology, and spinocerebellar ataxias with and without genetic confirmation)

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
• Clinical diagnosis of multiple system atrophy (MSA) or Friedrich's ataxia (FA)
• 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 the participants 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
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ataxia; 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

Results Point of Contact

• Title: Cherie Marvel
• Organization: Johns Hopkins University

cmarvel1@jhmi.edu

410-387-8510

Study Officials

• Cherie Marvel, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: March 14, 2023
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

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)