To compare the presence of freezing of gait in levodopa-naïve patients with Parkinson*s disease from Tanzania/Brazil with the presence of freezing of gait in Dutch Parkinson patients (matched for disease duration) who have received chronic pulsatile…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence and severity of freezing of gait will be assessed subjectively
using the New-Freezing of gait Questionnaire. Moreover, the presence of
freezing of gait will be objectified using the timed-up-and-go test, and four
rapid 360-degrees turns in both directions.
Secondary outcome
Phenotype of freezing of gait.
Background summary
Freezing of gait is among the most mysterious and dramatic symptoms in patients
with Parkinson*s disease. Although freezing is both common and disabling, its
pathophysiological substrate remains to be unravelled. Levodopa is the current
*gold-standard* symptomatic treatment for Parkinson*s disease. An increase in
the dosage of levodopa is also the *gold-standard* treatment for freezing of
gait in Parkinson*s disease. Shortly after the introduction of levodopa in the
sixties of the previous century, two publications suggested that levodopa
resulted in a clear increase in freezing of gait. However, these early
observations did not receive any further attention in the decades that
followed. In 2018 and 2019, I have published historical studies on untreated
Parkinson patients with severe disease, suggesting that chronic levodopa might
be the very culprit in causing freezing of gait. My work also suggested that
the phenotype of freezing changes after the introduction levodopa treatment,
with freezing with attempted stepping occurring significantly more often. This
hypothesis is provocative and in need of further evidence. To obtain this,
out-of-the-box methods are needed, as it is unethical to purposely withhold
levodopa from patients with Parkinson*s disease for several years. I therefore
aim to perform an observational study in sub-Saharan Africa/South-America,
where levodopa is generally unavailable and unaffordable. I will compare the
presence and phenotype of freezing of gait in the African/South-American cohort
with the presence of freezing of gait in a matched cohort in the Netherlands.
Study objective
To compare the presence of freezing of gait in levodopa-naïve patients with
Parkinson*s disease from Tanzania/Brazil with the presence of freezing of gait
in Dutch Parkinson patients (matched for disease duration) who have received
chronic pulsatile levodopa treatment.
Study design
Observational cohort study in Tanzania/Brazil and the Netherlands.
Study burden and risks
Patient recruited from the Netherlands will be assessed OFF-dopaminergic
medication, which is expected to cause an increase in Parkinsonian symptoms,
during the measurement day. However, this is an internationally accepted and
applied procedure, without risks.
Reinier Postlaan 4 Reinier postlaan 4
Nijmegen 6500 HB
NL
Reinier Postlaan 4 Reinier postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
In Tanzania/Brazil, I will include 75 patients with idiopathic Parkinson*s
disease who have not been treated with any form of dopaminergic medication
(including Mucuna pruriens, which is a tropical legume native to Africa, rich
of levodopa). In the Netherlands, I will include 75 patients who have received
levodopa-treatment (patients will be matched for disease duration, age and
gender).
In both cohorts, patients should have a disease duration of at least 5 years,
because freezing is rare for patients with a shorter disease duration.
Exclusion criteria
Exclusion criteria include significant co-morbidity limiting the interpretation
of ambulation and inability to walk unaided.
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 | NL72917.091.20 |