VCR: A Treatment for Early Stage Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT05545826
• Recruitment Status: Not yet recruiting
• First Posted: September 19, 2022
• Last Update Posted: December 7, 2022
• Sponsor: Stanford University
• Information provided by (Responsible Party): Peter Tass, MD, PhD, Stanford University

Study Description

Brief Summary:

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage Parkinson's symptoms. VCR will be administered with a device called the vibrotactile axon Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Device: Vibrotactile coordinated reset	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease
• Estimated Study Start Date: February 1, 2023
• Estimated Primary Completion Date: October 20, 2025
• Estimated Study Completion Date: October 20, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vibrotactile Coordinated Reset (vCR); Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.	Device: Vibrotactile coordinated reset; The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with early stage Parkinson's disease

Outcome Measures

Primary Outcome Measures :

1. Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III change from baseline to 24 months. [ Time Frame: 24 months ]
   This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment.

Secondary Outcome Measures :

1. Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months. [ Time Frame: 24 months ]
   The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems.
2. Freezing of gait questionnaire (FOG) change from change from baseline to 24 months. [ Time Frame: 24 months ]
   The FOGQ assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). The FOG is comprised of 6 questions measured on a 0 to 4 scale (where 0 is normal and 4 represents severe abnormalities). The scores are summed together with 0 representing the best possible score and 24 representing the worst possible score.
3. Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months. [ Time Frame: 24 months ]
   The MDS-UPDRS part 1 focuses on non-motor symptoms, such as dementia, depression, and psychosis. The total summed score ranges from 0-52 with higher scores indicating increased non-motor impairment.
4. Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months. [ Time Frame: 24 months ]
   The MDS-UPDRS part 2 focuses on the patient's ability to perform daily motor activities including dressing, grooming, and using utensils. The total summed score ranges from 0-52 with higher scores indicating increased daily motor impairment.
5. Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months. [ Time Frame: 24 months ]
   The MDS-UPDRS 4 focuses on Measures the complications of treatment, e.g. dyskinesias and motor fluctuations. The total summed score ranges from 0-24 with higher scores indicating increased motor complications.
6. Spontaneous EEG beta band power change from baseline to 24 months. [ Time Frame: 24 months ]
   Patients will be recorded while receiving vibrotactile stimulation. The Beta Band (13-30Hz) power spectral density (PSD) will be of interest. The units of the power spectral density are micro-Volts-squared per Hz. Increases in Beta band PSD are associated with motor impairment in Parkinson's disease, while decreases in the beta band are associated with motor improvement.
7. Smell Identification change from baseline change from baseline to 24 months. [ Time Frame: 24 months ]
   Patients will smell 16 pens filled with a specific odor. One point is given to a correctly identified smell. The score is range from 0 to 16 with lower scores indicating smell loss.
8. Smell threshold change from baseline to 24 months. [ Time Frame: 24 months ]
   Thresholds are obtained in a three alternative forced choice paradigm where subjects are repeatedly presented with triplets of pens and have to discriminate one pen containing an odorous solution from two blanks filled with the solvent. Sixteen concentrations are created by stepwise diluting previous ones by 1:2. Starting with the lowest odor concentration, a staircase paradigm is used where two subsequent correct identifications of the odorous pen or one incorrect answer marked a so-called turning point, and results in a decrease or increase of concentration in the next triplet. The threshold score is the mean of the last four turning points in the staircase, with the final score ranging between 1 and 16 points, with lower scores indicating an increased smell threshold.
9. Smell discrimination change from baseline to 24 months. [ Time Frame: 24 ]

   Smell discrimination is obtained in a three alternative forced choice paradigm where subjects are repeatedly presented with triplets of pens and in which 2 have the same odorant and 1 has a different smell. Subjects were asked to indicate the single pen with a different smell.

   The score is the sum of correctly identified odors. The scores in this task ranged from 0 to 16 points, which lower scores indicating a decrease in smell discrimination

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age at the time of enrollment: 35 - 90 years
2. Idiopathic Parkinson's Symptoms between hoehn and yahr stage 1
3. Fluent in English
4. If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording
5. Appropriate social support if required during an off state.
6. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
7. Feels comfortable going off PD related medication during in person study visits
8. Lives in the United States

Exclusion Criteria:

1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
2. Any current drug or alcohol abuse.
3. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
4. Pregnancy, breast-feeding or wanting to become pregnant
5. Physical limitations unrelated to PD that would affect motor ratings
6. Craniotomy with the exception of burr holes.
7. Brain surgery
8. Patient is unable to communicate properly with staff (i.e., severe speech problems)
9. Excessive drooling
10. A type of hairstyle that would impede the use of an EEG cap
11. Sensory abnormalities of the fingertips
12. Nasal Disfunction unrelated to smell loss -

Contacts and Locations

Contacts

Contact: Jessica Yankulova; 650-474-9547; jessky@stanford.edu

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

Principal Investigator: Peter Tass, MD, Ph.D

Sponsors and Collaborators

Stanford University

More Information

• Responsible Party: Peter Tass, MD, PhD, Protocol Director, Stanford University
• ClinicalTrials.gov Identifier: NCT05545826
• Other Study ID Numbers: 67304
• First Posted: September 19, 2022
• Last Update Posted: December 7, 2022
• Last Verified: December 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases