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

NCT ID: NCT05436249

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2024-01-15

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

Study Design

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

Study Groups

Real time neurofeedback with task

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

Group Type: OTHER

Neurofeedback treatment

Intervention Type: 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).

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.

Group Type: OTHER

At-home therapy

Intervention Type: 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.

Interventions

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 slider bar that indicates the success of recruiting predicted brain regions (consistent with those engaged during overt tapping).

Intervention Type: DEVICE

At-home therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: collaborator

Johns Hopkins Discovery Award

UNKNOWN

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

Other Identifiers

IRB00281329

Identifier Type: -

Identifier Source: org_study_id