Clinical trial NCT05436262: Using Real-time fMRI Neurofeedback and Motor Imagery to Enhance Motor Timing and Precision in Cerebellar Ataxia
Official title: Using Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery to Enhance Motor Timing and Precision in Cerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellar Ataxia
Spinocerebellar Ataxias
Cerebellar Degeneration
Keywords: Cerebellar Ataxia
Spinocerebellar Ataxias
Cerebellar Diseases
Neurodegenerative Diseases
Cerebellum
Gait
Balance
Movement Disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-06-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


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

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 During Imagery and Finger Tapping Accuracy Improvements 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 Flashing Cross 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 Accuracy of the Flashing Cross 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: