N/A
N=11
The Role of Cerebellar Hyperactivity in Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02349789 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change in Gait Speed- Sham_On — -0.0185 meters per second (m/s)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gait Speed- Sham_On |
-0.0185 | — |
| PRIMARY Change in Gait Speed- Sham_Off |
0.0078 | — |
| PRIMARY Change in Gait Speed- Anodal_On |
-0.0477 | — |
| PRIMARY Change in Gait Speed- Anodal_Off |
0.0346 | — |
| PRIMARY Change in Gait Speed- Cathodal_On |
-0.0059 | — |
| PRIMARY Change in Gait Speed- Cathodal_Off |
-0.0502 | — |
Summary
Gait and balance disturbances are one of the most incapacitating symptoms of Parkinson's disease (PD) (Boonstra et al. 2008). They can cause falls and are therefore associated with the negative spiral of (near) falls, fear of falling, fractures, reduced mobility and social isolation; hence, having a profound negative impact on quality of life (Lin et al. 2012). Originally, symptoms of PD were ascribed to dopamine deficiency and basal ganglia dysfunction (Wu et al. 2013). However, in the last decades it has become clear that other brain structures are also involved in the pathophysiology of PD (Snijders et al. 2011; Stefani et al. 2007). An intriguing, emerging insight is that the cerebellum may be involved in the pathophysiology of PD (Wu et al. 2013). That is, the cerebellum is hyperactive in PD patients during different motor tasks (Yu et al. 2007; Hanakawa et al. 1999; del Olmo et al. 2006). However, whether cerebellar hyperactivity is pathological or compensatory and how it affects gait and balance in PD patients remain open questions. Here, the investigators aim to elucidate the role of the hyperactive cerebellum in gait dysfunction in PD patients by modulating cerebellar excitability with state-of-the-art non-invasive brain stimulation techniques and investigate the effects on gait.
Eligibility Criteria
Inclusion Criteria
- Mild-moderate (Hoehn and Yahr scale: 1.5-3) idiopathic, akinetic-rigid type Parkinson's disease.
- Capable of walking for 5 minutes.
Exclusion Criteria
- Severe dyskinesia
- Congestive heart failure.
- Peripheral artery disease with claudication.
- Cancer. Pulmonary or renal failure. Unstable angina. Uncontrolled hypertension (> 190/110 mmHg). Brain injury. History of seizure or a family history of epilepsy. Metal anywhere in the head except the mouth. Cardiac pacemakers. Cochlear implants. Implanted medication pump. Heart disease. Intracardiac lines. Increased intracranial pressure, such as after infarctions or trauma. Currently taking tricyclic anti-depressants or neuroleptic medication. History of head trauma. History of respiratory disease. Dementia (Montreal Cognitive Assessment < 26; Frontal Assessment Battery < 13). Orthopedic or pain conditions. Pregnancy.
Data sourced from ClinicalTrials.gov (NCT02349789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.