Trial Outcomes & Findings for Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS (NCT NCT02549859)

NCT ID: NCT02549859

Last Updated: 2020-10-29

Results Overview

A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid \& food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Immediately following treatment for at least 30 minutes
• Results posted on: 2020-10-29

Participant Flow

15 patients were screened for eligibility at a hospital-associated specialty clinic in Chicago, IL.

Eleven of 15 screened participants were enrolled; four did not meet inclusion/exclusion criteria. Five of the enrolled participants had participated in a previous study and had been treated on 60Hz DBS since then; their Visit 1 (V1) measurements were taken from the previous study.

Participant milestones

Measure	Deep Brain Stimulation (DBS) All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.
Visit 1 STARTED	11
Visit 1 COMPLETED	11
Visit 1 NOT COMPLETED	0
Long-term 60 Hz DBS STARTED	11
Long-term 60 Hz DBS COMPLETED	10
Long-term 60 Hz DBS NOT COMPLETED	1
Visit 2 STARTED	10
Visit 2 COMPLETED	10
Visit 2 NOT COMPLETED	0

Reasons for withdrawal

Measure

Deep Brain Stimulation (DBS) All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.

Long-term 60 Hz DBS Study Closed

1

Baseline Characteristics

Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS

Baseline characteristics by cohort

Measure	Deep Brain Stimulation (DBS) n=11 Participants All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	6 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Parkinson's Disease Duration	14.2 years STANDARD_DEVIATION 5.7 • n=5 Participants
DBS at High Frequency Stimulation Duration	3.5 years STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration & a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid & food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1	0.6 score on a scale Standard Deviation 0.8	2.9 score on a scale Standard Deviation 2.1	1.2 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1	1.1 score on a scale Standard Deviation 1.0	3.3 score on a scale Standard Deviation 2.1	3.1 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Freezing of Gait Questionnaire at Visit 1	3.0 score on a scale Standard Deviation 3.7	9.3 score on a scale Standard Deviation 4.1	5.1 score on a scale Standard Deviation 3.8

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Stand-Walk-Sit Freezing of Gait Spells at Visit 1	0.1 score on a scale Standard Deviation 0.2	3.0 score on a scale Standard Deviation 3.8	1.6 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Stand-Walk-Sit Time at Visit 1	22.1 seconds Standard Deviation 7.1	28.5 seconds Standard Deviation 8.5	23.6 seconds Standard Deviation 6.0

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration & a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid & food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2	2.0 score on a scale Standard Deviation 2.4	3.0 score on a scale Standard Deviation 2.5	2.4 score on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2	4.8 score on a scale Standard Deviation 6.9	7.4 score on a scale Standard Deviation 8.9	5.7 score on a scale Standard Deviation 6.9

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Freezing of Gait Questionnaire at Visit 2	5.9 score on a scale Standard Deviation 4.4	11.2 score on a scale Standard Deviation 4.1	7.0 score on a scale Standard Deviation 4.0

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Stand-Walk-Sit Freezing of Gait Spells at Visit 2	2.2 score on a scale Standard Deviation 3.8	6.1 score on a scale Standard Deviation 7.0	2.5 score on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Stand-Walk-Sit Time at Visit 2	26.5 seconds Standard Deviation 12.2	38.4 seconds Standard Deviation 26.0	27.8 seconds Standard Deviation 11.9

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1	22.8 score on a scale Standard Deviation 10.4	33.7 score on a scale Standard Deviation 8.3	34.4 score on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1	3.8 score on a scale Standard Deviation 3.3	8.9 score on a scale Standard Deviation 3.4	6.9 score on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1	11.7 score on a scale Standard Deviation 5.3	16.6 score on a scale Standard Deviation 4.6	17.1 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1	4.0 score on a scale Standard Deviation 2.4	4.9 score on a scale Standard Deviation 2.5	6.0 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 1

The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.

Outcome measures

Measure	DBS 60Hz n=11 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=11 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=11 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1	1.8 score on a scale Standard Deviation 2.2	1.2 score on a scale Standard Deviation 2.1	2.5 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2	27.1 score on a scale Standard Deviation 9.1	32.4 score on a scale Standard Deviation 7.1	31.4 score on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2	6.8 score on a scale Standard Deviation 4.7	10.4 score on a scale Standard Deviation 3.9	8.1 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2	12.8 score on a scale Standard Deviation 3.5	16.3 score on a scale Standard Deviation 2.3	15.7 score on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2	4.3 score on a scale Standard Deviation 2.2	3.8 score on a scale Standard Deviation 2.1	4.8 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Immediately following treatment for at least 30 minutes

Population: Participants completing Visit 2

The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.

Outcome measures

Measure	DBS 60Hz n=10 Participants Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS 130Hz n=10 Participants Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.	DBS Off n=10 Participants Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2	1.6 score on a scale Standard Deviation 2.6	0.2 score on a scale Standard Deviation 0.7	1.2 score on a scale Standard Deviation 2.0

Adverse Events

DBS 60Hz

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DBS 130Hz

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DBS Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ms. Lani Leong, Research Coordinator

University of Chicago

Phone: 7738341688

Email: lani@neurology.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place