Rhythmic Auditory Stimulation (RAS) for Gait in Parkinson's Patients with DBS
This study is looking at how Rhythmic Auditory Stimulation (RAS) affects walking in people with Parkinson's disease (PD) who have Deep Brain Stimulation (DBS). RAS uses rhythmic sounds, like a metronome, to help you walk. Researchers want to see if RAS can improve your walking speed, how many steps you take per minute (cadence), and how long your steps are (stride length). They will also look at brain activity. You can join if you are 18-89 years old, have Parkinson's, and have a specific type of DBS device. The study plans to enroll 10 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention (RAS). It plans to include 10 participants.
- What's involved
- You will be asked to walk with metronome beats during your DBS ON and OFF states for four minutes each. This will take place during an additional up to 1 hour after a routine clinic visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- Gait parameters will be measured before, during, and immediately after RAS, at specific time points within a 30-minute period.
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Effects of RAS on Gait in PD Patients With DBS
At a glance
Conditions
NCT05763732
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Johns Hopkins School of Medicine
Baltimore, Marylandno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alexander Pantelyat, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Change in gait cadence (steps/minute)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 velocity (meter/minute)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
- Change in gait stride length (meter)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
- Changes in MDS-UPDRS-III (section 3.9. Arising From Chair ) score0 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 3.10. Gait) score0 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) score0 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 3.12. Postural stability) score0 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 3.13. Posture) score0 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.