The Role of Cerebellar Hyperactivity in Parkinson's Disease

NCT02349789 | Completed Results

• 1 other identifier: IRB00052263
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Keywords

Gait; Cerebellum; Non invasive electrical stimulation; tDCS; TMS; Balance

Outcome Measures

Primary Outcomes (6)

• Change in Gait Speed- Sham_On

  Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants on medication.

  One session

• Change in Gait Speed- Sham_Off

  Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants off medication.

  One session

• Change in Gait Speed- Anodal_On

  Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants on medication.

  One session

• Change in Gait Speed- Anodal_Off

  Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants off medication.

  One session

• Change in Gait Speed- Cathodal_On

  Change in overground walking speed (10 meter walk test) after Cathodal transcranial direct current stimulation, participants on medication.

  One session

• Change in Gait Speed- Cathodal_Off

  Change in overground walking speed (10 meter walk test) after cathodal transcranial direct current stimulation, participants off medication.

  One session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with Parkinson's disease

You may qualify if:

• Mild-moderate (Hoehn and Yahr scale: 1.5-3) idiopathic, akinetic-rigid type Parkinson's disease.
• Capable of walking for 5 minutes.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Johns Hopkins University: collaborator
• University of Twente: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Anthony Gonzalez
• Organization: Kennedy Krieger Institute

gonzalezan@kennedykrieger.org

4439080074

Study Officials

• Amy Bastian, PT, PhD

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., PT

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 29, 2015
• Study Start: January 28, 2015
• Primary Completion: October 4, 2016
• Study Completion: September 1, 2017
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2017-12

Locations

US (1)