The primary objective of this study is to compare the brain activity of PD patients with prominent balance or gait impairments while they mentally imagine swaying or walking respectively.A secondary objective of this study is to compare the brain…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Movement disorders, Parkinson's disease, postural instability and gait disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To avoid confounding influences of actual movements, subjects are instructed to
mentally simulate the act of swaying and walking, but without actually
performing it (*motor imagery*). To characterize the neural circuit underlying
gait control in PD, we use a validated motor imagery protocol. To characterize
the neural circuit underlying postural control, we extend this approach and
apply a newly developed protocol for motor imagery of balance that closely
matches the protocol used for gait. Specifically, we will use a dynamic balance
task (imagining to sway on a balance board), because this is clinically more
relevant than static balance. By asking subjects to alternately imagine walking
or sway, we can directly contrast and isolate the neural substrates of gait and
postural control. Finding differences in neural substrate between gait and
balance would have great fundamental and clinical implications. First, this
would imply that gait impairment and postural instability result from different
pathologies in the brain. Second, this would help to create a model for
designing specific therapeutic approaches that are required to combat each of
these
symptoms.
Secondary outcome
Secondary parameters include:
- Comparing the brain activity of PD patients with balance impairments and a
group of healthy subjects while they mentally imagine swaying
- Using clinical and objective assessments of gait and balance as covariates in
the analyses.
Background summary
Postural instability and gait disturbances are among the most incapacitating
features of Parkinson*s disease (PD), both for patients and their caregivers.
Better pathophysiological insights are needed to provide a rational basis for
improved treatment strategies. It is widely assumed that the neural substrate
is identical for gait and balance problems. We propose a new pathophysiological
scenario, suggesting that although gait impairment and postural instability may
temporally coincide in PD, they have distinct neural substrates.
Study objective
The primary objective of this study is to compare the brain activity of PD
patients with prominent balance or gait impairments while they mentally imagine
swaying or walking respectively.
A secondary objective of this study is to compare the brain activity of PD
patients with balance impairments and a group of healthy subjects while they
mentally imagine swaying.
Study design
We will test the hypothesis according to which gait and balance have distinct
neural substrates using functional magnetic resonance imaging (fMRI) to
document brain activity during task performance.
Study burden and risks
The experimental protocol will consist of clinical assessments, performance of
a gait and a balance task and imagination of the performed gait and balance
tasks while in an fMRI scanner. These measurements will be performed on two
separate mornings, within one week. These two mornings, the patients will
arrive in a practically defined OFF state, that is 8-12 hours after withdrawal
of antiparkinsonian medication (Langston et al., 1992). By the end of the
experiment, medication intake will be resumed according to each patients'
prescription. During the time of medication withdrawal, a resurgence of the
parkinsonian symptoms is very likely, which might cause discomfort for the
patients. However, the experiment including the fMRI measurement do not pose
any risk, if appropriate precautions are taken. The noise and the relative
confined space of the MRI scanner may however cause some discomfort to some
subjects.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
Parkinson's disease patients
• Men/women of age > 18 years.
• written informed consent
• idiopathic PD, according to the UK Brain Bank Criteria.
• disease severity 2.5, 3 or 4 on the Hoehn & Yahr scale (gait and/or balance disorders but still able to walk/stand independently.;Controls
• right-handed men/women of age > 18 years
• written informed consent
Exclusion criteria
Parkinson disease patients
• patients with levodopa*induced gait or balance disorders (e.g., levodopa*induced freezing of gait). We will therefore exclude patients who score greater on levodopa than off levodopa on the gait, balance or freezing items of the UPDRS.
• failure to lay still for 90 minutes in the scanner (for example due to head tremor or medication-induced excessive movement)
• failure to stand/walk independently
• other causes of clinically relevant gait difficulties (eg, orthopedic or vestibular disorders)
• contra*indications for MR scanning (eg, clautrophobia)
• other neurological disorders such as stroke in history or a psychiatric disease
• depression
• cognitive impairment (MMSE <26).
• severe comorbidity (eg cancer)
• pregnancy
• poor eyesight;Controls
• failure to lay still for 90 minutes in the scanner (for example due to head tremor or medication-induced excessive movement)
• failure to stand/walk independently
• causes of clinically relevant gait/balance difficulties (eg, orthopedic or vestibular disorders)
• contra*indications for MR scanning (eg, claustrophobia).
• any neurological disorders such as stroke in history or a psychiatric disease
• depression
• cognitive impairment (MMSE <26).
• severe comorbidity (eg cancer)
• pregnancy
• poor eyesight
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41481.091.12 |
| OMON | NL-OMON25618 |