Clinical trial NCT05436249: Use of Real-Time Functional Magnetic Resonance Imaging Neurofeedback to Improve Motor Function in Cerebellar Ataxia
Official title: Using Motor Imagery and Machine Learning-Based Real-Time fMRI Neurofeedback to Improve Motor Function in Cerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Cerebellar Ataxia
Healthy Controls
Ataxia
Spinocerebellar Ataxias
Cerebellar Diseases
Neurodegenerative Diseases
Movement Disorders
Cerebellum
Gait
Balance
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
name: Johns Hopkins Discovery Award
First posted: 2022-06-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed
timeFrame: Baseline and MRI duration, up to 1 hour
measure: Change in overt tapping accuracy as assessed by finger tapping to a flashing cue at 4Hz speed
timeFrame: Baseline and MRI duration, up to 1 hour
measure: Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 1Hz speed
timeFrame: Baseline and At-home sessions (10 minutes/day), up to 23 days
measure: Change in at-home overt tapping accuracy as assessed by finger tapping to a flashing cue at 4Hz speed
timeFrame: Baseline and At-home sessions (10 minutes/day), up to 23 days
Secondary outcomes:
measure: The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 1Hz as assessed by a correlation coefficient
timeFrame: MRI duration, up to 1 hour
measure: The correlation between MRI BOLD and finger tapping accuracy to a flashing cue at 4Hz as assessed by a correlation coefficient
timeFrame: MRI duration, up to 1 hour
measure: The correlation between the KVIQ and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient
timeFrame: Up to 1.5 hours
measure: The correlation between the ICARS and imagery accuracy of the slider bar from target on the MRI task as assessed by a correlation coefficient
timeFrame: Up to 1.5 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cherie Marvel, PhD
role: PRINCIPAL_INVESTIGATOR
References: