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Clinical Trials/NL-OMON25618
NL-OMON25618
Recruiting
N/A

Postural instability and gait disability: related but separable manifestations of Parkinson’s disease

Donders Institute for Brain, Cognition and BehaviorCentre for Cognitive NeuroimagingRadboud University Medical Centre, Nijmegen, The Netherlands0 sites50 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Donders Institute for Brain, Cognition and BehaviorCentre for Cognitive NeuroimagingRadboud University Medical Centre, Nijmegen, The Netherlands
Enrollment
50
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Sponsor
Donders Institute for Brain, Cognition and BehaviorCentre for Cognitive NeuroimagingRadboud University Medical Centre, Nijmegen, The Netherlands

Eligibility Criteria

Inclusion Criteria

  • Parkinson's disease patients
  • right\-handed 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.
  • gait and/or balance impairments that remain present during an optimal ON state, i.e. after a challenge with a supramaximal levodopa dosage. For this purpose, we will use criteria used previously in neurosurgery studies by our collaborators in Grenoble, and define ‘gait impairment’ as a UPDRS part III score ≥2 for the Gait item. Similarly, postural instability will be defined as a UPDRS III score ≥2 for the Pull test item, or a score ≥2 for the item ‘Falls unrelated to freezing’ of the UPDRS part II.
  • 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

Outcomes

Primary Outcomes

Not specified

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