Parkinson's DiseaseNCT02349789
The Role of Cerebellar Hyperactivity in Parkinson's Disease
An observational study of Parkinson's Disease, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2015to Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Parkinson's disease
Who may be able to join
- Mild-moderate (Hoehn and Yahr scale: 1.5-3) idiopathic, akinetic-rigid type Parkinson's disease.
- Capable of walking for 5 minutes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
Official title: Stimulating the Little Brain to Make Big Steps: Improving Gait in Parkinson's Disease Patients by Non-invasive Electrical Stimulation of the Cerebellum.
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.
Read the detailed description
The cerebellum plays an important role in generating well-coordinated locomotion, voluntary limb movements and eye movements (Morton et al. 2004). It is particularly important for balance and limb coordination needed to generate a stable gait pattern (Morton et al. 2006). Specific roles of the cerebellum for gait include coordinating the two legs to produce a stable rhythmic pattern, dynamic regulation of balance, and adaptation of the pattern through practice (Morton et al. 2004). Though the core deficits of PD patients are largely different than those of cerebellar patients, they do show decreased bilateral coordination (Plotnik et al. 2008) and a fundamental disturbance in stride length regulation (Morris et al. 1998) during walking.
Recent work has shown that the cerebellum is hyperactive in PD patients, though it is not known whether this activity is compensatory (i.e. reduces motor impairments) or pathological (i.e. causes motor impairments). One idea is that increased cerebellar activity, affecting cerebral motor areas, compensates for the reduced drive from the basal ganglia (Wu et al. 2013). Alternatively, it is possible that cerebellar hyperactivity is pathological, as recent work suggests that cerebellar activity may be partially responsible for the generation of Parkinsonian tremor (Helmich et al. 2012). One approach to answer this question is to use non-invasive brain stimulation techniques to decrease the activity of the cerebellum in PD patients and determine if they improve or worsen their gait pattern.
Non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are able to alter the excitability of brain pathways. Applying these techniques over the motor cortex, improved motor function in different patient groups, including stroke and PD (Benninger et al. 2010). Only two studies have investigated the effect of modulation of cerebellar-motor cortex excitability on motor function in PD patients. That is, 1 Hz repetitive TMS (inhibitory rTMS) over the cerebellum improved gross arm movements, but worsened fine motor skills17. Furthermore, a two-week continuous theta burst stimulation TMS protocol decreased levodopa-induced dyskinesias (Koch et al. 2009). These studies only investigated the effects on the upper extremities. The cerebellum is also hyperactive during gait (Hanakawa et al. 1999; del Olmo et al. 2006), but whether modulation of cerebellar excitability can improve gait deficits in PD patients is currently unknown.
Non-invasive brain stimulation can also be used to study the connection between the cerebellum and the motor cortex via using paired-pulse TMS. Specifically, cerebellar stimulation 5 ms before motor cortex stimulation leads to a reduction in the amplitude of motor-evoked potentials (MEPs), a phenomenon referred to as cerebellar-brain inhibition (CBI) (Pinto et al. 2001). This measure of CBI is abnormal in PD patients-it is reduced at rest, but increases with muscle contraction (Ni et al. 2010).
Gait impairments in PD are often resistant to treatment, particularly as the disease progresses. Therefore, insight in the pathophysiology of gait disturbances is essential for improving treatment options and quality of life for PD patients. This study will answer the question of whether cerebellar hyperactivity alleviates or worsens gait deficits in PD patients. If cerebellar hyperactivity in PD is compensatory, anodal (i.e. excitatory) tDCS should improve gait in PD patients, whereas cathodal (i.e. inhibitory) tDCS will make matters worse. In contrast, if cerebellar hyperactivity is pathological, cathodal tDCS will improve gait and anodal tDCS will worsen it. Hence, this study will improve the fundamental understanding of gait pathophysiology in PD patients. The investigators will focus on the aspects of gait that are particularly affected in PD and associated with fall risk, such as stride length and gait speed (Paul et al. 2013). In this way, this study may identify the cerebellum as a potential new target for treatment, opening up new possibilities improving gait and balance disturbances in PD.
- Conditions
- Parkinson's Disease
- Keywords
- Gait, Cerebellum, Non invasive electrical stimulation, tDCS, TMS, Balance
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed- Sham_On
Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants on medication.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study start28 Jan 2015
- Primary completion4 Oct 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Twente
- Responsible party
- Principal investigator, Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Amy Bastian, PT, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349789
- Sponsor's protocol ID
- IRB00052263
- Status last verified
- Dec 2017
- First submitted
- 26 Jan 2015
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating the Little Brain to Make Big Steps: Improving Gait in Parkinson's Disease Patients by Non-invasive Electrical Stimulation of the Cerebellum.
- ClinicalTrials.gov ID
- NCT02349789
- Acronym / sponsor ID
- IRB00052263
- Conditions
- Parkinson's Disease
- Keywords
- Gait, Cerebellum, Non invasive electrical stimulation, tDCS, TMS, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Johns Hopkins University, University of Twente
- Study start
- 28 Jan 2015 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- Sep 2017
- First posted
- 29 Jan 2015 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The cerebellum plays an important role in generating well-coordinated locomotion, voluntary limb movements and eye movements (Morton et al. 2004). It is particularly important for balance and limb coordination needed to generate a stable gait pattern (Morton et al. 2006). Specific roles of the cerebellum for gait include coordinating the two legs to produce a stable rhythmic pattern, dynamic regulation of balance, and adaptation of the pattern through practice (Morton et al. 2004). Though the core deficits of PD patients are largely different than those of cerebellar patients, they do show decreased bilateral coordination (Plotnik et al. 2008) and a fundamental disturbance in stride length regulation (Morris et al. 1998) during walking.
Recent work has shown that the cerebellum is hyperactive in PD patients, though it is not known whether this activity is compensatory (i.e. reduces motor impairments) or pathological (i.e. causes motor impairments). One idea is that increased cerebellar activity, affecting cerebral motor areas, compensates for the reduced drive from the basal ganglia (Wu et al. 2013). Alternatively, it is possible that cerebellar hyperactivity is pathological, as recent work suggests that cerebellar activity may be partially responsible for the generation of Parkinsonian tremor (Helmich et al. 2012). One approach to answer this question is to use non-invasive brain stimulation techniques to decrease the activity of the cerebellum in PD patients and determine if they improve or worsen their gait pattern.
Non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are able to alter the excitability of brain pathways. Applying these techniques over the motor cortex, improved motor function in different patient groups, including stroke and PD (Benninger et al. 2010). Only two studies have investigated the effect of modulation of cerebellar-motor cortex excitability on motor function in PD patients. That is, 1 Hz repetitive TMS (inhibitory rTMS) over the cerebellum improved gross arm movements, but worsened fine motor skills17. Furthermore, a two-week continuous theta burst stimulation TMS protocol decreased levodopa-induced dyskinesias (Koch et al. 2009). These studies only investigated the effects on the upper extremities. The cerebellum is also hyperactive during gait (Hanakawa et al. 1999; del Olmo et al. 2006), but whether modulation of cerebellar excitability can improve gait deficits in PD patients is currently unknown.
Non-invasive brain stimulation can also be used to study the connection between the cerebellum and the motor cortex via using paired-pulse TMS. Specifically, cerebellar stimulation 5 ms before motor cortex stimulation leads to a reduction in the amplitude of motor-evoked potentials (MEPs), a phenomenon referred to as cerebellar-brain inhibition (CBI) (Pinto et al. 2001). This measure of CBI is abnormal in PD patients-it is reduced at rest, but increases with muscle contraction (Ni et al. 2010).
Gait impairments in PD are often resistant to treatment, particularly as the disease progresses. Therefore, insight in the pathophysiology of gait disturbances is essential for improving treatment options and quality of life for PD patients. This study will answer the question of whether cerebellar hyperactivity alleviates or worsens gait deficits in PD patients. If cerebellar hyperactivity in PD is compensatory, anodal (i.e. excitatory) tDCS should improve gait in PD patients, whereas cathodal (i.e. inhibitory) tDCS will make matters worse. In contrast, if cerebellar hyperactivity is pathological, cathodal tDCS will improve gait and anodal tDCS will worsen it. Hence, this study will improve the fundamental understanding of gait pathophysiology in PD patients. The investigators will focus on the aspects of gait that are particularly affected in PD and associated with fall risk, such as stride length and gait speed (Paul et al. 2013). In this way, this study may identify the cerebellum as a potential new target for treatment, opening up new possibilities improving gait and balance disturbances in PD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Parkinson's disease
Key inclusion criteria (2 listed)
- Mild-moderate (Hoehn and Yahr scale: 1.5-3) idiopathic, akinetic-rigid type Parkinson's disease.
- Capable of walking for 5 minutes.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Gait Speed- Sham_On
Time frame: One session
Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants on medication.
Change in Gait Speed- Sham_Off
Time frame: One session
Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants off medication.
Change in Gait Speed- Anodal_On
Time frame: One session
Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants on medication.
Change in Gait Speed- Anodal_Off
Time frame: One session
Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants off medication.
Change in Gait Speed- Cathodal_On
Time frame: One session
Change in overground walking speed (10 meter walk test) after Cathodal transcranial direct current stimulation, participants on medication.
Change in Gait Speed- Cathodal_Off
Time frame: One session
Change in overground walking speed (10 meter walk test) after cathodal transcranial direct current stimulation, participants off medication.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Bastian, PT, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Speed- Sham_On (time frame: One session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.