The primary objective is to test whether rhythmic somatosensory input (vibrotactile stimulation at tremor frequency) reduces tremor power of Parkinson*s tremor, as compared to other vibrotactile stimulation settings (continuous stimulation,…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of vibrotactile stimulation at tremor frequency on tremor severity
(delta tremor power between stimulation and baseline).
Secondary outcome
The effect of continuous vibrotactile stimulation, stimulation at 1.5 times
tremor frequency and sham on tremor severity (delta tremor power between
stimulation/sham and baseline).
The effect of continuous vibrotactile stimulation on bradykinesia (average
button presses per second in the keyboard finger tapping test during
stimulation versus sham).
The effect of vibrotactile stimulation at step frequency on gait, with three
outcome measures of Timed up and go performance: Time to complete, number of
freezing episodes and duration of freezing episodes.
Background summary
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 suggest 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 that are involved in tremor
are also responsive to somatosensory stimulation. Somatosensory afferents may
thus play a role in tremor pathophysiology and could therefore be used as
treatment target. Here, we will test this hypothesis by investigating the
effect of modulating somatosensory input (with vibrotactile stimulation) on
tremor severity.
Study objective
The primary objective is to test whether rhythmic somatosensory input
(vibrotactile stimulation at tremor frequency) reduces tremor power of
Parkinson*s tremor, as compared to other vibrotactile stimulation settings
(continuous stimulation, stimulation at 1.5 times tremor frequency, sham
stimulation). As secondary objectives, we will test whether the effect of
vibrotactile stimulation on tremor power depends on the context in which tremor
occurs (rest, cognitive coactivation, posture) and whether vibrotactile
stimulation has an effect on two other common PD symptoms: impaired gait and
bradykinesia.
Study design
Cross-sectional exploratory intervention study.
Intervention
The intervention involves subtle mechanical vibrations (vibrotactile
stimulation) 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).
Study burden and risks
The load on patients consists of the time spent on this project, and
potentially a temporary worsening of symptoms caused by withholding medication.
Patients will arrive in a practically defined OFF state, i.e. at least 12 hours
after having taken their last dopaminergic medication. At the end of the
measurement, they will resume their normal medication regime. All measurements
are non-invasive, painless, and without nuclear radiation. Individual
participants do not directly benefit from participation. However, we 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.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
-18-80 years old
-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
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)
-Montreal cognitive assessment (MoCA) score < 20 or previously documented
dementia
-Unable to walk without walking aid.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL77202.091.21 |