Effects of Rhythmic Auditory Stimulation (RAS) on Gait in Parkinson Disease (PD) Patients With DBS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in gait velocity (meter/minute)
研究概览
简要总结
Participants will be asked to walk along with the metronome beats (RAS) during the participants' stimulation state (ON or OFF) for four minutes for each state.
The researcher will collect the gait parameters (cadence, velocity, and stride length) of patients before, during, and after RAS in both DBS ON and OFF states.
Using MDS-UPDRS, participants' gait patterns will be collected before and after RAS while both DBS is ON and OFF. Electrophysiological activity (local field potentials, LFPs) will be collected across all stages (pre, during, and post-RAS) of evaluation.
详细描述
Given the evidence that rhythmic auditory stimulation (RAS) can modulate beta oscillation and improve gait parameters, the purpose of this study is to examine behavioral and neurophysiological rhythmic entrainment mechanisms.
Participants who complete the consent and enrollment process will remain for an additional up to 1 hour following the participants' routine clinic visit at the Jons Hopkins Outpatient Clinic.
The protocol will consist of two parts (DBS ON and DBS OFF). The order of stimulation states will be randomly assigned to the participants.
During DBS ON, participants will receive the participants' previously optimized stimulation after a 10-minute washout period. The researchers will measure participants' gait parameters (cadence, velocity, and stride length) with a 2-minute walk (a set distance of 10 meters during the 2-minute walk) and gait patterns using relevant items from the MDS-UPDRS-III rating scale during stimulation ON (Pre-RAS).
The participants will then walk to the metronome beats for a total of four minutes (2 minutes for the same beat as baseline cadence and 2 minutes for 10% faster than baseline cadence) (RAS), and the gait parameters will be recorded. The order of the tempo will be randomized across the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and outcomes assessor will be masked to the participants' stimulation state (OFF or ON). However, they cannot be masked whether they will receive rhythmic auditory stimulation (RAS) or not (pre-RAS or post-RAS).
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Parkinson disease (PD) (and)
- •PD patients who implanted Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) with PerceptTM PC
排除标准
- •Inability or unwillingness to follow directions for study procedures
研究组 & 干预措施
Pre RAS
After a 10-minute washout period, participants will receive the participants' optimized stimulation.
- The participants will undergo assessments to measure gait parameters and patterns during stimulation ON and OFF (Pre-RAS) using the 10-meter walk (during a 2-minute walk) and MDS-UPDRS-III rating scale.
- Electrophysiological activity (e.g., local field potentials, LFPs) will be collected before assessments.
During RAS
- The participants will walk to the metronome beats for four minutes (2 minutes for the same beats as baseline cadence and 2 minutes for 10% faster than baseline cadence) (RAS), and the participants' gait parameters will be recorded.
- Electrophysiological activity (e.g., local field potentials, LFPs) will be collected.
干预措施: Rhythmic Auditory Stimulation (RAS) (Behavioral)
Post RAS
The same assessment as the Pre-RAS will be conducted (Post-RAS).
结局指标
主要结局
Change in gait velocity (meter/minute)
时间窗: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes
Gait velocity will be calculated with a 10-meter walk. Velocity(meter/min) = 60 / time (seconds) x 10 meter
Changes in MDS-UPDRS-III (section 3.9. Arising From Chair ) score
时间窗: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
0: Normal: No problems. Able to arise quickly without hesitation. 1. Slight: Arising is slower than normal; or may need more than one attempt; or may need to move forward in the chair to arise. No need to use the arms of the chair. 2. Mild: Pushes self up from the arms of the chair without difficulty. 3. Moderate: Needs to push off, but tends to fall back; or may have to try more than one time using the arms of the chair, but can get up without help. 4. Severe: Unable to arise without help.
Change in MDS-UPDRS-III (section 3.12. Postural stability) score
时间窗: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
0: Normal: No problems. Recovers with one or two steps. 1. Slight: 3-5 steps, but subject recovers unaided. 2. Mild: More than 5 steps, but subject recovers unaided. 3. Moderate: Stands safely, but with absence of postural response; falls if not caught by examiner. 4. Severe: Very unstable, tends to lose balance spontaneously or with just a gentle pull on the shoulders.
Change in MDS-UPDRS-III (section 3.10. Gait) score
时间窗: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
0: Normal: No problems. 1. Slight: Independent walking with minor gait impairment. 2. Mild: Independent walking but with substantial gait impairment. 3. Moderate: Requires an assistance device for safe walking (walking stick, walker) but not a person. 4. Severe: Cannot walk at all or only with another person's assistance.
Change in MDS-UPDRS-III (section 3.11. Freezing of gait) score
时间窗: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
0: Normal: No freezing. 1. Slight: Freezes on starting, turning, or walking through doorway with a single halt during any of these events, but then continues smoothly without freezing during straight walking. 2. Mild: Freezes on starting, turning, or walking through doorway with more than one halt during any of these activities, but continues smoothly without freezing during straight walking. 3. Moderate: Freezes once during straight walking. 4. Severe: Freezes multiple times during straight walking.
Change in MDS-UPDRS-III (section 3.13. Posture) score
时间窗: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
0: Normal: No problems. 1. Slight: Not quite erect, but posture could be normal for older person. 2. Mild: Definite flexion, scoliosis or leaning to one side, but patient can correct posture to normal posture when asked to do so. 3. Moderate: Stooped posture, scoliosis or leaning to one side that cannot be corrected volitionally to a normal posture by the patient. 4. Severe: Flexion, scoliosis or leaning with extreme abnormality of posture.
Change in gait cadence (steps/minute)
时间窗: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes
Gait cadence will be calculated with a 10-meter walk. Cadence (steps/min) = 60 / time (seconds) x # of steps
Change in gait stride length (meter)
时间窗: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes
Gait stride length will be calculated with a 10-meter walk. Stride length (meter) = Velocity / Cadence x 2
次要结局
- Change in power spectrum density of Local Fields Potential (LFP) (micro-volts-squared per Hz)(0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes)