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

NCT ID: NCT05436262

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2024-01-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Real-time fMRI with neurofeedback of motor imagery

Intervention Type: 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 motor imagery practice sessions

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.

Group Type: EXPERIMENTAL

Real-time fMRI with neurofeedback of motor imagery

Intervention Type: DEVICE

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

Interventions

Real-time fMRI with neurofeedback of motor imagery

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18-100 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)

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cherie Marvel, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21NS125546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00300264

Identifier Type: -

Identifier Source: org_study_id