Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease 2

Parkinson Disease Clinical Trial

Official title:

Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881460
• Other study ID #: 25412
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: January 21, 2025

Study information

• Verified date: July 2023
• Source: Synergic Medical Technologies, Inc.
• Contact: Jeff Kraakevik, MD
• Phone: 503-494-8311
• Email: kraakevi[@]ohsu.edu
• 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 motor function in people with Parkinson's disease (PD). vCR will be administered with a device called the Vibrotactile (VT) Touch device. vCR can be used in conjunction with medication and is expected to delay the need to increase dopamine medication. It also provides a more flexible alternative to deep brain stimulation (DBS) in that the vCR therapy can be easily stopped or modified to better suit the patients' needs.

Description:

This vCR study will include a crossover design, where participants are their own control and receive both active stimulation and sham, aiding in understanding true treatment effects from vCR.

Current treatments for PD include medications, surgical measures, or a combination of both. However, long term use of medications can result in intolerable side effects, especially at higher doses. Although DBS is FDA approved and an established method to manage symptoms of PD, it is an invasive and expensive procedure and may not improve all symptoms of PD. The team at Synergic Medical Technologies, Inc. developed a non-invasive method of applying vibrotactile stimulation delivered through the fingertips that has the potential of theoretically disrupting abnormal synchrony in the brain and thus alleviate severity in motor symptoms in people with PD.

The purpose of this study is to test the use of vibrotactile stimulation on 30 participants with PD and vCRs effects on motor ability using the VT Touch.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 21, 2025
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 45-85

2. Diagnosis of idiopathic Parkinson's disease from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following: rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar, or proprioceptive conditions

3. Bilateral, moderate-stage impairment, as defined as Hoehn & Yahr Stages II-IV in the on-medication state

4. Able to walk and stand unassisted

5. Participants must be on a stable regimen of PD medication (at least 4 weeks prior to enrollment)

6. Responsive to levodopa (self-reported)

7. Willing to keep exercise and medication regimen as stable as possible for the duration of the study

8. Able to provide informed consent

9. Independently, or with social support, able to use technology and access virtual meeting if needed to troubleshoot technology

10. Participants must speak English and can communicate with staff

11. Patients live close to or in the area of where the clinic is located and are able to travel to the clinic for all screening and assessment appointments.

Exclusion Criteria:

1. Severe depression or suicide ideation (as assessed with Beck Depression Inventory (BDI), BDI <28, and Columbia Suicide Severity Rating scale (SSRS), C-SSRS < 4)

*BDI score > 28, indicating severe depression that precludes ability to adhere to protocol. Any subject with such a score will be referred to a Primary Care Physician (PCP) or physician for further evaluation and management of depression. Individuals with a BDI score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression.

2. Presence of other neurological or musculoskeletal disorders as determined by the physician during screening.

3. Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month

4. Physical limitations unrelated to Parkinson's disease

5. Recent change or addition of psychoactive medications for non-parkinsonian treatments

6. Any kind of brain surgery or neurostimulators

7. Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Active vibrotactile coordinated reset
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.
• Sham vibrotactile coordinated reset
Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.

Locations

Country	Name	City	State
United States	Oregon Health & Science Institution	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Synergic Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3	Difference in MDS-UPDRS Part 3 from baseline to 2 months between active and sham. Range is 0-72 (18 items with 4 being max for each item), higher being worse	baseline, 2 months, 3 months, 5 months
Secondary	Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab	Difference in APDM gait speed from baseline to 2 months between active and sham	baseline, 2 months, 3 months, 5 months
Secondary	Quality of life improvements	Quality of life improvements as measured by the Parkinson's disease Quality of Life questionnaire (PDQ-39)	baseline, 2 months, 3 months, 5 months
Secondary	Change in freezing severity index	Change in freezing severity index quantified during a turning in place task and other gait spatio-temporal parameters	baseline, 2 months, 3 months, 5 months