The Effect of Vibrotactile Stimulation on Parkinson's Tremor

NCT05152836 | Completed DMC

• 2 other identifiers: NL77202.091.212021-12968
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Tremor in Parkinson's disease is a common and highly burdensome symptom. Recent evidence shows that areas in the brain that are underlying Parkinson's tremor overlap with those that respond to somatosensory stimulation. Applying such stimulation to the tremulous limb might therefore influence tremor-related brain activity and thereby potentially reduce tremor. In this study, the investigators explore this possibility and investigate whether tremor specific vibrotactile stimulation at the wrist of the most affected arm influences tremor severity.

Conditions

Parkinson Disease; Tremor

Keywords

Parkinson disease; Vibrotactile stimulation; Tremor

Outcome Measures

Primary Outcomes (2)

• The effect of vibrotactile stimulation at tremor frequency on tremor severity with active control

  The investigators will investigate the effect of frequency specific stimulation compared to an active control condition, averaged across three different contexts (rest/posture/cognitive coactivation). Specifically, we will test the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (bursts at tremor frequency vs. bursts at 1.5 times tremor frequency).

  25 minutes

• The effect of continuous vibrotactile stimulation on tremor severity

  The investigators will investigate the effect of continuous stimulation compared to sham stimulation, averaged across three different contexts (rest/posture/cognitive coactivation). Specifically, we will test the change in log transformed tremor power from baseline to stimulation, as a function of stimulation setting (continuous 80Hz stimulation vs. sham). For the two primary outcomes measures, Bonferroni correction will be applied to correct for multiple comparisons.

  25 minutes

Secondary Outcomes (6)

• The effect of vibrotactile stimulation at tremor frequency on tremor severity with passive control

  25 minutes

• The effect of continuous vibrotactile stimulation on bradykinesia

  10 minutes

• The effect of vibrotactile stimulation on gait

  10 minutes

• The effect of vibrotactile stimulation on freezing

  10 minutes

• Investigating the effect of vibrotactile stimulation at tremor frequency on tremor severity in 3 different contexts

  25 minutes

Study Arms (1)

Vibrotactile stimulation atdifferent settings

EXPERIMENTAL

All participants receive vibrotactile stimulation at three different stimulation settings as well as one sham condition. Specifically, stimulation is applied at (1) brief bursts of 80Hz that occur at the individual tremor frequency, (2) 80Hz bursts at tremor frequency\*1.5, and (3) continuous stimulation at 80Hz. The sham condition does not involve any stimulation. All of the stimulations will be applied under three different contextual manipulations: during rest, posture and cognitive coactivation (serial subtraction task). Within each context, stimulation/sham conditions are applied in random order.

Device: Vibrotactile stimulation at tremor frequency; Device: Vibrotactile stimulation at tremor frequency*1.5; Device: Vibrotactile stimulation at continuous stimulation; Device: Vibrotactile stimulation 10% below and above step frequency

Interventions

Vibrotactile stimulation at tremor frequency DEVICE

Mechanical vibrations are applied at brief bursts of 80Hz that occur at the individual tremor frequency. Vibrations are delivered via a small device, which is worn on the wrist of the most-affected arm.

Vibrotactile stimulation atdifferent settings

Vibrotactile stimulation at tremor frequency*1.5 DEVICE

Mechanical vibrations are applied at 80Hz bursts at individual tremor frequency\*1.5. Vibrations are delivered via a small device, which is worn on the wrist of the most-affected arm.

Vibrotactile stimulation atdifferent settings

Vibrotactile stimulation at continuous stimulation DEVICE

Continuous 80Hz stimulation is applied via a small device worn on the wrist of the most-affected arm.

Vibrotactile stimulation atdifferent settings

Vibrotactile stimulation 10% below and above step frequency DEVICE

This intervention is applied during assessment of gait. Two devices are worn on both ankles which allows alternating stimulation of both ankles with brief bursts of 80 HZ at the individual step frequency plus or minus 10%.

Vibrotactile stimulation atdifferent settings

Eligibility Criteria

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

You may qualify if:

• years old and able to provide informed consent
• Have a diagnosis of idiopathic PD made by a movement disorders specialist
• Medically optimized without planned medication changes for the duration of the study • Resting tremor subscore \>/= 2 of the most-affected arm on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) item 2.10
• Postural tremor subscore \>/= 1 of the most-affected arm on the MDS-UPDRS item 3.15
• Signed informed consent

You may not qualify if:

• The presence of additional neurologic diseases that might confound testing or the coexistence of PD and essential tremor together (action tremor that was present prior to the development of parkinsonism)
• Moderate to severe peripheral neuropathy (reduced vibratory sensation) at the upper extremities, quantified with a graduated tuning fork
• Montreal cognitive assessment (MoCA) score \< 20 or previously documented dementia
• Unable to walk without walking aid

Sponsors & Collaborators

• Donders Centre for Cognitive Neuroimaging: lead
• Parkinson's Foundation: collaborator

Study Sites (1)

Donders Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor

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

• Rick C. Helmich, MD PhD

  Radboud University Nijmegen Medical Centre Donders Institute for Brain, Cognition and Behavior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 10, 2021
• Study Start: November 30, 2021
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)