Trial · NCT05871151

Combining VNS With PT Interventions for Individuals With PD

NCT05871151, Not applicable, Completed, University of Alabama at Birmingham; results first posted 2025-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combining VNS With PT Interventions for Individuals With PD. Trials, record NCT05871151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05871151

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combining VNS With PT Interventions for Individuals With PD
NCT number: NCT05871151
Status: Completed
Phases: Not applicable
Enrollment: 25 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Parkinson Disease
Interventions: taVNS, Exercise
First posted: 2023-05-23
Last updated: 2025-12-17
Results first posted: 2025-12-17
Limitations and caveats: Small sample size limits the statistical power and precludes definitive conclusions about efficacy. Blinding integrity was not maintained

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	In our study, we will utilize the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. This scale, widely used in the clinical and research settings, helps us evaluate the motor symptoms of Parkinson's Disease. The MDS-UPDRS Part III scale ranges from 0 to 132, with 0 representing no motor symptoms and 132 representing severe motor symptoms. Therefore, a higher score on the MDS-UPDRS Part III scale indicates a worse outcome, reflecting more severe motor symptoms associated with Parkinson's disease.
Primary	Six Minute Walk Test (6MWT)	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	6-Minute Walk Test (6MWT): We utilize the 6-Minute Walk Test in our study to evaluate the functional exercise capacity of our participants. The 6MWT involves participants walking as far as they can in a span of six minutes on a flat, hard surface. The total distance covered in six minutes is recorded as the score. In this test, a greater distance indicates better physical endurance and mobility. Therefore, in our study, a higher score (greater distance walked) on the 6MWT represents a better outcome, signifying superior functional exercise capacity.
Primary	Ten Meter Walk Test (10MWT)	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	The 10MWT is a timed walking test commonly used in clinical and research settings to assess an individual's gait speed and functional mobility. It measures the time it takes for a person to walk a distance of 10 meters (approximately 33 feet). The scale title, in this case, is the time in seconds required to complete the 10-meter walk. There are no specific minimum and maximum values for this measure since it depends on the individual's walking ability. However, lower scores (i.e., shorter times) generally indicate better outcomes, as they reflect faster gait speed and improved mobility. Conversely, higher scores (longer times) would suggest slower walking speed and potentially poorer functional mobility.
Primary	Mini-Best Test	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment tool used to evaluate a person's balance and stability. It consists of 14 items that assess different aspects of balance, including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait, and stability during functional tasks. The scale title for the Mini-BESTest is the total score, which ranges from 0 to 28. Higher scores on the Mini-BESTest indicate better balance performance and greater overall stability. A score of 28 represents the best possible outcome, indicating excellent balance abilities across all assessed domains. Conversely, lower scores indicate poorer balance control and increased risk of falls.
Primary	Functional Gait Assessment (FGA)	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	The Functional Gait Assessment (FGA) is a clinical measure used to assess an individual's walking ability and functional mobility. It evaluates various aspects of gait, including balance, coordination, range of motion, and adaptability. The FGA consists of 10 different tasks or conditions that challenge the person's walking abilities in different ways, such as walking while turning, walking over obstacles, or walking with eyes closed. The scale title for the FGA is the total score, which ranges from 0 to 30. Higher scores on the FGA indicate better functional gait performance and greater walking independence. A score of 30 represents the best possible outcome, reflecting excellent gait function across all assessed conditions. Conversely, lower scores suggest impaired gait function and reduced functional mobility.
Primary	mCTSIB	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	The modified Clinical Test of Sensory Interaction on Balance (mCTSIB) is a diagnostic tool used to evaluate an individual's sensory integration and balance control. It assesses the person's ability to maintain balance under various sensory conditions. The mCTSIB involves four different standing positions, each with different sensory inputs: (1) feet together on a firm surface with eyes open, (2) feet together on a firm surface with eyes closed, (3) feet together on a foam surface with eyes open, and (4) feet together on a foam surface with eyes closed. The results presented in this section reflect the participant's composite mCTSIB score as measured by the BTrack Balance System. Composite scores range from 0 to 400. Higher scores indicate better balance control and greater sensory integration.
Secondary	MoCA	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	The Montreal Cognitive Assessment (MoCA) is a widely accepted tool in both clinical and research settings, allowing us to evaluate cognitive abilities, specifically focusing on attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA scale ranges from 0 to 30, with a score of 30 indicating the highest level of cognitive function. Lower scores on the MoCA suggest a higher level of cognitive impairment. Therefore, in the context of our study, a higher score on the MoCA represents a better outcome, signifying superior cognitive performance.
Secondary	DKEFS Color Word Interference Test - Condition One	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	Delis-Kaplan Executive Function System (D-KEFS) Color Word Interference Test is used to assess cognitive flexibility and inhibitory control. Condition 1 is basic naming of color patches. All D-KEFS raw scores are converted to scaled scores, with a mean of 10 and a standard deviation of 3, corrected for each of the following 16 age-groups:8, 9, 10, 11, 12, 13, 14, 15, 16-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80-89. Higher scores indicate better performance.
Secondary	DKEFS Color Word Interference Test - Condition Two	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	Delis-Kaplan Executive Function System (D-KEFS) Color Word Interference Test is used to assess cognitive flexibility and inhibitory control. Condition 2 is basic reading of color-words printed in black ink. All D-KEFS raw scores are converted to scaled scores, with a mean of 10 and a standard deviation of 3, corrected for each of the following 16 age-groups:8, 9, 10, 11, 12, 13, 14, 15, 16-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80-89. Higher scores indicate better performance.
Secondary	DKEFS Color Word Interference - Condition Three	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	Delis-Kaplan Executive Function System (D-KEFS) Color Word Interference Test is used to assess cognitive flexibility and inhibitory control. Condition 3 is the traditional Stroop task, for which the examinee must inhibit reading the words in order to name the dissonant ink colors in which those words are printed. All D-KEFS raw scores are converted to scaled scores, with a mean of 10 and a standard deviation of 3, corrected for each of the following 16 age-groups:8, 9, 10, 11, 12, 13, 14, 15, 16-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80-89. Higher scores indicate better performance.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)		Scores on a scale	MEAN
PRIMARY	Six Minute Walk Test (6MWT)	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	One participant in the sham group and one in the active group did not complete the 6MWT at follow-up. One participant in the sham group did not complete the 6MWT at post-test.	feet	MEAN
PRIMARY	Ten Meter Walk Test (10MWT)	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	Self-selected gait speed	seconds	MEAN
PRIMARY	Mini-Best Test	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)		Scores on a scale	MEAN
PRIMARY	Functional Gait Assessment (FGA)	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)		Scores on a scale	MEAN
PRIMARY	mCTSIB	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)		Scores on a scale	MEAN
SECONDARY	MoCA	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)		Scores on a scale	MEAN
SECONDARY	DKEFS Color Word Interference Test - Condition One	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	One participant in the sham group did not complete the CWI.	Scores on a scale	MEAN
SECONDARY	DKEFS Color Word Interference Test - Condition Two	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)		Scores on a scale	MEAN
SECONDARY	DKEFS Color Word Interference - Condition Three	Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)	One of the participants in the sham group did not complete CWI-3 at follow-up.	Scores on a scale	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group96

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	active taVNS + exercise	Baseline	31.00	Standard Deviation 12.68419839	Scores on a scale
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	sham taVNS + exercise	Baseline	36.70	Standard Deviation 8.602971063	Scores on a scale
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	active taVNS + exercise	Post-treatment	25.1	Standard Deviation 11.51279481	Scores on a scale
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	sham taVNS + exercise	Post-treatment	26.8	Standard Deviation 12.51488003	Scores on a scale
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	active taVNS + exercise	Follow-up	24.5	Standard Deviation 9.969397619	Scores on a scale
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	sham taVNS + exercise	Follow-up	32.3	Standard Deviation 8.525126262	Scores on a scale
Six Minute Walk Test (6MWT)	active taVNS + exercise	Baseline	1411.94	Standard Deviation 137.6766598	feet
Six Minute Walk Test (6MWT)	sham taVNS + exercise	Baseline	1366	Standard Deviation 272.5831168	feet
Six Minute Walk Test (6MWT)	active taVNS + exercise	Post-treatment	1566	Standard Deviation 196.4051934	feet
Six Minute Walk Test (6MWT)	sham taVNS + exercise	Post-treatment	1448.111111	Standard Deviation 323.8643406	feet

1 to 10 of 96Source ClinicalTrials.gov

See all 96 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	active taVNS + physical therapy	11
Overall Study	STARTED	sham taVNS + physical therapy	11
Overall Study	COMPLETED	active taVNS + physical therapy	10
Overall Study	COMPLETED	sham taVNS + physical therapy	10
Overall Study	NOT COMPLETED	active taVNS + physical therapy	1
Overall Study	NOT COMPLETED	sham taVNS + physical therapy	1

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	active taVNS + exercise	10
Total, all-cause mortality	sham taVNS + exercise	10
Total, other adverse events	active taVNS + exercise	10
Total, other adverse events	sham taVNS + exercise	10
Total, serious adverse events	active taVNS + exercise	10
Total, serious adverse events	sham taVNS + exercise	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42347126	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
active taVNS + exercise vs sham taVNS + exercise: deaths from any cause	Trial comparisons
active taVNS + exercise vs sham taVNS + exercise: serious adverse events	Trial comparisons

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Digit Span Test	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition
Symbol Coding	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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