The primary objective is to study how brain and muscles work together during the onset of walking, during turns and during prolonged walking and whether there are differences between healthy individuals and PD patients with and without FOG.…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measures of cortico-cortical, cortico-muscular and musculo-muscular coupling
(derived from dynamic coherence analysis) during the different tasks, compared
between patients with and without FOG and controls. In addition, measures of
gait such as step duration, gait velocity and walking rhythm during the
different tasks, compared between patients and controls.
Secondary outcome
NA
Background summary
Freezing of Gait (FOG) is a frequent and disabling feature of Parkinson*s
Disease (PD), that is characterized by an inability to walk, which can occur
e.g. at the start of walking, when turning, in confined spaces such as doorways
or even mid-walking in open spaces in more severe cases. The pathophysiology of
FOG is unknown. Most neuroimaging techniques have difficulties measuring brain
signals during walking, making it difficult to study the underlying neural
substrates responsible for FOG. With the new wireless combined EEG-EMG
technique we can measure brain and muscle activity while participants walk
under ecologically valid circumstances, hopefully leading to more understanding
regarding the neural control of locomotion and FOG in particular.
Study objective
The primary objective is to study how brain and muscles work together during
the onset of walking, during turns and during prolonged walking and whether
there are differences between healthy individuals and PD patients with and
without FOG. Secondary objectives are to evaluate the differences in step
duration, gait velocity and walking rhythm between PD patients with and without
FOG and healthy controls, the role of motor timing in walking and FOG and the
influence of dual tasking in walking and FOG.
Study design
Observational study.
During the tasks electrical brain activity will be registered using 32-channel
EEG integrated in a cap. EMG will be recorded simultaneously from different leg
muscles. Furthermore, inertial measurement units (IMUs; integrating
accelerometers, gyroscopes and magnetometers in a matchbox-like container) will
be placed on the shank to allow movement analysis. After measurement
preparation the participant has to perform the following tasks:
1. Repeated 10 meter walk test (at their own pace)
2. Repeated 6 meter walk-turn-walk test (at their own pace)
3. Straight-line walking during approximately 3-5 minutes (at their own pace)
4. Synchronization-continuation task; this task is used to quantify how
accurate participants can time their steps to a rhythmic auditory beat
(synchronization phase) and then maintain this rhythm after the external
auditory cue is extinguished, where performance depends on an internal
representation of the beat (continuation phase).
5. Dual task (walking and e.g., counting backwards by 3*s or executing a verbal
fluency task), which is expected to induce FOG.
Other parameters of interest (medication use and comorbidities) will be
collected from the patient*s file. Moreover, participants will be videoed
during task execution to allow visual analysis of the walking pattern and
identification of FOG, according to the clinical gold standard.
The study will consist of a pilot study and a case-control study in which PD
patients with and without FOG will be compared to healthy age- and sex-matched
controls.
Study burden and risks
There are no risks or benefits, and the burden is limited to the time invested
in the test (approximately 2 hours, with breaks).
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Healthy individuals:
o Perceived healthy
o Age >= 18 years, age- and sex-matched with PD patients without FOG for case-control study
o Right-handed according to the Annett Handedness scale
o Written informed consent
All PD Patients:
o able to walk properly (Hoehn & Yahr scale: Stage 2-3)
o PD diagnosis according to the UK Parkinson*s Disease Society Brain Bank criteria (A.J. Hughes, 1992)
o Age < 70 (to limit the presence of vascular problems)
o Right-handed according to the Annett Handedness scale
o Written informed consent
PD patients without FOG:
o self-reported absence of FOG
o Score=0 on (Dutch translation of) Giladi*s FOG questionnaire (Giladi et al., 2000)
o Absence of FOG on clinical examination during rapid bidirectional 360* turns and dual tasking (Snijders et al., 2012)
PD patients with FOG:
o self-reported FOG
o Score >=1 on (Dutch translation of) Giladi*s FOG questionnaire (Giladi et al., 2000) or presence of FOG on clinical examination during rapid bidirectional 360 degree turns and dual tasking (Snijders et al., 2012)
Exclusion criteria
All participants
• Mini Mental State Examination (MMSE) score <26 (to exclude low task performance due to cognitive disabilities)
• (other) neurological or motor disorder (for patients: other than PD)
• Use of medication influencing movement (for patients: other than for PD)
PD patients
• Tremor-dominant PD
Design
Recruitment
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 | NL55519.042.15 |