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Behavioural Intervention
Vibrotactile Stimulation for Parkinson's Disease
N/A
Recruiting
Led By Jeff Kraakivk, MD
Research Sponsored by Synergic Medical Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 months, 5 months, 9 months
Awards & highlights
Study Summary
This trial studies a new therapy, vCR, to help delay the need for more medication in people with Parkinson's. It's an alternative to deep brain stimulation (DBS) and can be easily stopped or modified.
Who is the study for?
This trial is for people aged 45-85 with moderate-stage Parkinson's disease who respond to levodopa, are on stable PD meds, and can walk unassisted. They must be able to use technology, live near the clinic, and not be in other trials or have conditions that could interfere.Check my eligibility
What is being tested?
The study tests a non-invasive device called Vibrotactile (VT) Touch which delivers vibrotactile coordinated reset stimulation (vCR). It aims to improve motor function in Parkinson's patients and may delay the need for increased dopamine medication.See study design
What are the potential side effects?
Since vCR uses a non-invasive device without drugs, side effects might be minimal but could include discomfort at the site of stimulation or skin irritation from the device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 months, 5 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 months, 5 months, 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Secondary outcome measures
Change in freezing severity index
Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab
Quality of life improvements
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active vibrotactile coordinated resetActive Control1 Intervention
Participants will receive active Vibrotactile Coordinated Reset stimulation.
Group II: Sham vibrotactile coordinated resetPlacebo Group1 Intervention
Participants will receive inactive Vibrotactile Coordinated Reset stimulation.
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Who is running the clinical trial?
Synergic Medical Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Jeff Kraakivk, MDPrincipal InvestigatorOregon Health and Science University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Parkinson's disease is at a moderate stage.I respond well to levodopa.I have been diagnosed with Parkinson's disease by a specialist.I can walk and stand without help.I live near the clinic and can travel there for all appointments.I have been on a stable Parkinson's disease medication regimen for at least 4 weeks.I have had brain surgery or have a neurostimulator.My doctor found I have a nerve or muscle disorder during my check-up.I speak English and can communicate with the staff.I have physical limitations not caused by Parkinson's disease.I can use technology on my own or with help for virtual meetings.I am between 45 and 85 years old.I recently started or changed medication for a mental health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Active vibrotactile coordinated reset
- Group 2: Sham vibrotactile coordinated reset
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does one have to be over the age of 45 to qualify for this medical experiment?
"People aged 45 to 85 are eligible for this clinical trial."
Answered by AI
Is this research opportunity open to new participants?
"To be accepted into this trial, individuals must possess a diagnosis of Parkinson's disease and between the ages 45 to 85. This medical research is seeking around 30 participants."
Answered by AI
How many participants are being enrolled in this experiment?
"Yes, according to records on clinicaltrials.gov this trial is in its recruitment stage. It was established on May 22nd 2023 and updated most recently on May 19th 2023; they are searching for 30 participants to be recruited from a single medical centre."
Answered by AI
Are there any available vacancies in this clinical trial?
"Yes, the portal clinicaltrials.gov affirms that this medical research is currently seeking participants. The trial was initially posted on May 22nd 2023 and recently revised on May 19th 2023; 30 patients are needed to be enrolled from one site."
Answered by AI
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