Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05504902
• Other study ID #: 66691
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR 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.

Description:

This study involves gentle vibrations delivered to the finger-tips which have been shown in pilot studies to be effective in reducing motor symptoms associated with Parkinson's Disease.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 92 Years

Eligibility

Inclusion Criteria:

1. Age at the time of enrollment: 35 - 92 years

2. Idiopathic Parkinson's Symptoms between hoehn and yahr stages 2 to 4

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.

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

7. Brain surgery

8. Patient is unable to communicate properly with staff (i.e., severe speech problems)

9. Excessive drooling

10. A type of hair style that would impede the use of an EEG cap

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Vibrotactile coordinated reset
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Advanced stage Parkinson's disease

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III change from baseline, 6 months, 12 months, 18 months and 24 months, while patients are examined off medication)	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.	24 months
Secondary	Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months	LEDD is calculated as a daily sum of levodopa in each Parkinson's medication	24 months
Secondary	Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline, 6 months, 12 months, 18 months and 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.	24 months
Secondary	Freezing of Gait Questionnaire (FOG) change from baseline, 6 months, 12 months, 18 months and 24 months.	The Freezing of Gait questionnaire (FOG) assesses 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.	24 months
Secondary	Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline, 6 months, 12 months, 18 months and 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.	24 months
Secondary	Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline, 6 months, 12 months, 18 months and 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.	24 months
Secondary	Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline, 6 months, 12 months, 18 months and 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.	24 months
Secondary	Communicative Participation Item Bank (CPIB; Short Form) change from baseline, 6 months, 12 months, 18 months and 24 months.	The CPIB is a questionnaire that measures speech complications. The questionnaire is scored from 0 to 30, with a higher score indicating increased speech difficulties.	24 months
Secondary	Voice Handicap Index (VHI-10) change from baseline, 6 months, 12 months, 18 months and 24 months.	This questionnaire can be filled out by patients and assesses the impact that voice problems and limitations have on the individual's overall daily function. Questionnaire is scored from 0 to 40, with a higher score indicating increased speech difficulties.	24 months
Secondary	Spontaneous EEG beta band power change from baseline, 6 months, 12 months, 18 months and 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.	24 months
Secondary	Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline, 6 months, 12 months, 18 months and 24 months.	The PD-CFRS capture subjective daily functional cognitive decline among patients with Parkinson's disease over the past 2 weeks. The scale ranges from 0 to 24, with higher scores indicative of cognitive decline.	24 months
Secondary	Vibratory threshold change from baseline, 6 months, 12 months, 18 months, and 24 months.	Participants will be assessed for their perceptive threshold of vibration, or the lowest vibration amplitude perceived. This is determined by adjusting the amplitude of the experimental device.	24 months