The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

NCT ID: NCT05106816

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2022-09-20

Brief Summary

Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. In this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with Parkinson's disease (PD), essential tremor (ET), and dystonia.

Detailed Description

This study is to evaluate the feasibility, reliability, and clinical effects of Non-invasive vibrotactile stimulation (VTS) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. VTS Settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation.

The investigators will recruit 30 patients with PD who are between the ages of 18-80 years old and independently living in the community. The investigators will additionally recruit up to 5 patients with ET and up to 5 patients with dystonia.

Conditions

Parkinson Disease; Essential Tremor; Dystonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vibrotactile Continuous stimulation

Continuous stimulation

Group Type: EXPERIMENTAL

skin surface vibration

Intervention Type: OTHER

This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones.

Vibrotactile Intermittent stimulation

Intermittent stimulation

Group Type: EXPERIMENTAL

skin surface vibration

Intervention Type: OTHER

This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones.

Vibrotactile Sham

Sham stimulation

Group Type: SHAM_COMPARATOR

light skin surface vibration- SHAM

Intervention Type: OTHER

This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones. Worn at the lowest frequency will simulate the active arms with no potential change in symptoms.

Interventions

skin surface vibration

This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones.

Intervention Type: OTHER

light skin surface vibration- SHAM

This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones. Worn at the lowest frequency will simulate the active arms with no potential change in symptoms.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-80 and able to provide informed consent.
• Have a diagnosis of Parkinson's disease, essential tremor, or cervical dystonia made by a movement disorders specialist.
• Medically optimized without planned medication changes for the duration of the study.
• For patients with ET, they will have a score of at least 2 on items 5 and 6 of the Fahn-Tolosa-Marin (FTM) Tremor Rating Scale.
• For patients with dystonia, they will have abnormal dystonic postures of the head and not isolated head tremor

Exclusion Criteria

• The presence of additional neurologic diseases, that might confound testing or the coexistence of PD and ET together (action tremor that was present prior to the development of parkinsonism).
• Symptoms of peripheral neuropathy at the wrist (reduced vibratory, pinprick, or temperature sensation)
• Montreal cognitive assessment (MoCA) score < 20 or previously documented dementia
• Unable to walk without a walking aid (e.g. cane, stick, walker)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkinson's Foundation

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher W Hess, MD

Role: PRINCIPAL_INVESTIGATOR

Norman Fixel Institute for Neurological Diseases, University of Florida

Locations

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

Countries

United States

References

Charcot JM. Vibratory therapeutics.--The application of rapid and continuous vibrations to the treatment of certain diseases of the nervous system. 1892. J Nerv Ment Dis. 2011 Nov;199(11):821-7. doi: 10.1097/NMD.0b013e31823899bc. No abstract available.

Reference Type: BACKGROUND

PMID: 22048131 (View on PubMed)

Gassner H, Janzen A, Schwirtz A, Jansen P. Random Whole Body Vibration over 5 Weeks Leads to Effects Similar to Placebo: A Controlled Study in Parkinson's Disease. Parkinsons Dis. 2014;2014:386495. doi: 10.1155/2014/386495. Epub 2014 Oct 13.

Reference Type: BACKGROUND

PMID: 25371843 (View on PubMed)

Haas CT, Turbanski S, Kessler K, Schmidtbleicher D. The effects of random whole-body-vibration on motor symptoms in Parkinson's disease. NeuroRehabilitation. 2006;21(1):29-36.

Reference Type: BACKGROUND

PMID: 16720935 (View on PubMed)

Jobges EM, Elek J, Rollnik JD, Dengler R, Wolf W. Vibratory proprioceptive stimulation affects Parkinsonian tremor. Parkinsonism Relat Disord. 2002 Jan;8(3):171-6. doi: 10.1016/s1353-8020(01)00016-5.

Reference Type: BACKGROUND

PMID: 12039427 (View on PubMed)

Kapur SS, Stebbins GT, Goetz CG. Vibration therapy for Parkinson's disease: Charcot's studies revisited. J Parkinsons Dis. 2012;2(1):23-7. doi: 10.3233/JPD-2012-12079.

Reference Type: BACKGROUND

PMID: 23939405 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

202002167

Identifier Type: -

Identifier Source: org_study_id