Using Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback and Motor Imagery to Enhance Motor Timing and Precision in Cerebellar Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 1Hz Speed
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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:
- Overt finger tapping in time with a flashing cue.
- 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.
干预措施: Real-time fMRI with neurofeedback of motor imagery (Device)
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:
- Overt finger tapping in time with a flashing cue.
- 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.
干预措施: Real-time fMRI with neurofeedback of motor imagery (Device)
结局指标
主要结局
Change in Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 1Hz Speed
时间窗: Baseline and MRI duration, up to 1 hour
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.
Change in Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 4Hz Speed
时间窗: Baseline and MRI duration, up to 1 hour
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.
Change in At-home Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 1Hz Speed
时间窗: Baseline and At-home sessions (10 minutes/day), up to 23 days
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.
Change in At-home Overt Tapping Accuracy as Assessed by Finger Tapping to a Flashing Cue at 4Hz Speed
时间窗: Baseline and At-home sessions (10 minutes/day), up to 23 days
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.
次要结局
- 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)