Clinical trial NCT05763732: Effects of RAS on Gait in PD Patients With DBS
Official title: Effects of Rhythmic Auditory Stimulation (RAS) on Gait in Parkinson Disease (PD) Patients With DBS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Deep brain stimulation
Rhythmic auditory stimulation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Finally, after this 4-minute walk, the same assessment as for Pre-RAS will be conducted (Post-RAS).

Electrophysiological activity (local field potentials, LFPs) will be collected across all stages (pre, during, and post-RAS) of evaluation.

In DBS OFF, there will be a separate 10-minute washout period if it is taking place after DBS ON so that the participant's brain circuits can adjust to not being stimulated. Except for the DBS stimulation state, DBS OFF will follow the same protocol as DBS ON above.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Parkinson disease (PD) (and)
* PD patients who implanted Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) with PerceptTM PC

Exclusion Criteria:

* Inability or unwillingness to follow directions for study procedures

Primary outcomes:
measure: Change in gait cadence (steps/minute)
timeFrame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes
measure: Change in gait velocity (meter/minute)
timeFrame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes
measure: Change in gait stride length (meter)
timeFrame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes
measure: Changes in MDS-UPDRS-III (section 3.9. Arising From Chair ) score
timeFrame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
measure: Change in MDS-UPDRS-III (section 3.10. Gait) score
timeFrame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
measure: Change in MDS-UPDRS-III (section 3.11. Freezing of gait) score
timeFrame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
measure: Change in MDS-UPDRS-III (section 3.12. Postural stability) score
timeFrame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
measure: Change in MDS-UPDRS-III (section 3.13. Posture) score
timeFrame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes
Secondary outcomes:
measure: Change in power spectrum density of Local Fields Potential (LFP) (micro-volts-squared per Hz)
timeFrame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Alexander Pantelyat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fujioka T, Ross B, Trainor LJ. Beta-Band Oscillations Represent Auditory Beat and Its Metrical Hierarchy in Perception and Imagery. J Neurosci. 2015 Nov 11;35(45):15187-98. doi: 10.1523/JNEUROSCI.2397-15.2015.
citation: Naro A, Pignolo L, Sorbera C, Latella D, Billeri L, Manuli A, Portaro S, Bruschetta D, Calabro RS. A Case-Controlled Pilot Study on Rhythmic Auditory Stimulation-Assisted Gait Training and Conventional Physiotherapy in Patients With Parkinson's Disease Submitted to Deep Brain Stimulation. Front Neurol. 2020 Aug 4;11:794. doi: 10.3389/fneur.2020.00794. eCollection 2020.
citation: Fujioka T, Trainor LJ, Large EW, Ross B. Beta and gamma rhythms in human auditory cortex during musical beat processing. Ann N Y Acad Sci. 2009 Jul;1169:89-92. doi: 10.1111/j.1749-6632.2009.04779.x.
citation: Jimenez-Shahed J. Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson's disease and related disorders. Expert Rev Med Devices. 2021 Apr;18(4):319-332. doi: 10.1080/17434440.2021.1909471. Epub 2021 Apr 5.
citation: Gilron R, Little S, Perrone R, Wilt R, de Hemptinne C, Yaroshinsky MS, Racine CA, Wang SS, Ostrem JL, Larson PS, Wang DD, Galifianakis NB, Bledsoe IO, San Luciano M, Dawes HE, Worrell GA, Kremen V, Borton DA, Denison T, Starr PA. Long-term wireless streaming of neural recordings for circuit discovery and adaptive stimulation in individuals with Parkinson's disease. Nat Biotechnol. 2021 Sep;39(9):1078-1085. doi: 10.1038/s41587-021-00897-5. Epub 2021 May 3.
citation: Torrecillos F, Tinkhauser G, Fischer P, Green AL, Aziz TZ, Foltynie T, Limousin P, Zrinzo L, Ashkan K, Brown P, Tan H. Modulation of Beta Bursts in the Subthalamic Nucleus Predicts Motor Performance. J Neurosci. 2018 Oct 10;38(41):8905-8917. doi: 10.1523/JNEUROSCI.1314-18.2018. Epub 2018 Sep 4.