The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

NCT05106816 | Completed

• 1 other identifier: 202002167
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Essential Tremor; Dystonia

Keywords

Parkinson Disease; Essential tremor; Dystonia; Vibrotactile stimulation

Outcome Measures

Primary Outcomes (1)

• Quantitative Tremor Assessment

  An external accelerometer will be adhered to the skin of the dorsum of the hand and will be used to quantify displacement of the hand due to tremor in the following conditions: * 1\. Sitting at rest * 2\. Sitting with both arms outstretched * 3\. Sitting at rest while performing a distracting cognitive task * 4\. Transition from rest to posture (arms held directly in front of patient) for 10 seconds

  Baseline up to immediately after the sham intervention

Secondary Outcomes (3)

• Functional Dexterity Task (FDT)

  Baseline up to immediately after the sham intervention

• Reaction time task

  Baseline up to immediately after the sham intervention

• Timed-up-and-go (TUG) gait task

  Baseline up to immediately after the sham intervention

Study Arms (3)

Vibrotactile Continuous stimulation

EXPERIMENTAL

Continuous stimulation

Other: skin surface vibration

Vibrotactile Intermittent stimulation

EXPERIMENTAL

Intermittent stimulation

Other: skin surface vibration

Vibrotactile Sham

SHAM COMPARATOR

Sham stimulation

Other: light skin surface vibration- SHAM

Interventions

skin surface vibration 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 Continuous stimulation; Vibrotactile Intermittent stimulation

light skin surface vibration- SHAM 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.

Vibrotactile Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• Parkinson's Foundation: collaborator

Study Sites (1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location

Related Publications (5)

• 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.

  PMID: 22048131 BACKGROUND

• 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.

  PMID: 25371843 BACKGROUND

• 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.

  PMID: 16720935 BACKGROUND

• 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.

  PMID: 12039427 BACKGROUND

• 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.

  PMID: 23939405 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher W Hess, MD

  Norman Fixel Institute for Neurological Diseases, University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research subjects will be blinded regarding stimulation or sham and specific stimulation settings. Walking will be scored by a blinded rater for number of freezing episodes and walking completion time in seconds in the timed up and go task.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo tremor measurements and perform motor control tasks at baseline and during continuous vibratory stimulation and sham stimulation.

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 4, 2021
• Study Start: October 7, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)