The Effect of Vibrotactile Stimulation on Parkinson's Tremor

NCT ID: NCT05152836

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-05-19

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.

Detailed Description

Parkinson's disease (PD) is the second most common neurodegenerative disease, of which tremor is a common and highly burdensome symptom. The pathophysiology of tremor involves a cerebral network that consists of basal ganglia and a cerebello-thalamo-cortical motor circuit. Emerging evidence suggests that somatosensory input from the tremulous limb to the brain may influence this network. Specifically, tremor-related activity was observed in primary and secondary somatosensory cortex, and thalamic cells involved in tremor appear to be responsive to somatosensory stimulation as well. Somatosensory afferents may thus play a role in tremor pathophysiology and could therefore be used as treatment target. Here, the investigators will test this hypothesis by investigating the effect of modulating somatosensory input (with vibrotactile stimulation) on tremor severity.

The primary objectives are 1) to test whether rhythmic somatosensory input (vibrotactile stimulation) at tremor frequency reduces tremor power of Parkinson's tremor as compared to vibrotactile stimulation at 1.5 times tremor frequency and 2) whether continuous 80Hz vibrotactile stimulation reduces tremor power as compared to sham stimulation. As secondary objectives, the investigators will test whether the effect of vibrotactile stimulation on tremor power depends on the context in which tremor occurs (rest, cognitive coactivation, posture), whether stimulation at tremor frequency reduces tremor power as compared to sham stimulation, and whether vibrotactile stimulation has an effect on two other common PD symptoms: impaired gait and bradykinesia. The investigators will include 27 patients with Parkinson's disease and rest as well as postural tremor. The intervention involves subtle mechanical vibrations on the wrist or ankles. This is a non-invasive and painless way to provide somatosensory stimuli, in a continuous (80Hz) or rhythmic fashion (brief bursts of 80 Hz at tremor or step frequency).

The investigators expect that this study will provide mechanistic insights into if and how somatosensory (vibro-tactile) afferents influence the cerebral tremor circuit in Parkinson's disease, and may provide a solid basis for designing further clinical treatment studies.

Conditions

Parkinson Disease; Tremor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vibrotactile stimulation atdifferent settings

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.

Group Type: EXPERIMENTAL

Vibrotactile stimulation at tremor frequency

Intervention Type: 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 at tremor frequency*1.5

Intervention Type: 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 at continuous stimulation

Intervention Type: DEVICE

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

Vibrotactile stimulation 10% below and above step frequency

Intervention Type: 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%.

Interventions

Vibrotactile stimulation at tremor frequency

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.

Intervention Type: DEVICE

Vibrotactile stimulation at tremor frequency*1.5

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.

Intervention Type: DEVICE

Vibrotactile stimulation at continuous stimulation

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

Intervention Type: DEVICE

Vibrotactile stimulation 10% below and above step frequency

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%.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18-80 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

Exclusion Criteria

• 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

• 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

Donders Centre for Cognitive Neuroimaging

OTHER

Sponsor Role: lead

Responsible Party

Franziska Goltz

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rick C. Helmich, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Donders Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

2021-12968

Identifier Type: OTHER

Identifier Source: secondary_id

NL77202.091.21

Identifier Type: -

Identifier Source: org_study_id