Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04046055
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Craig Workman, University of Iowa

Brief Summary:

Parkinson's disease (PD) is the second most common neurodegenerative disorder and affects approximately 1 million people in the United States with total annual costs approaching 11 billion dollars. The most common symptoms of PD are tremor, stiffness, slowness, and trouble with balance/walking, which lead to severe impairments in performing activities of daily living. Current medical and surgical treatments for PD are either only mildly effective, expensive, or associated with a variety of side-effects. Therefore, the development of practical and effective add-ons to current therapeutic treatment approaches would have many benefits. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can affect brain activity and can help make long-term brain changes to improve functions like walking and balance. While a few initial research studies and review articles involving tDCS have concluded that tDCS may improve PD walking and balance, many results are not meaningful in real life and several crucial issues still prevent tDCS from being a useful add-on intervention in PD. These include the selection of stimulation sites (brain regions stimulated) and tDCS electrode placement. Most studies have targeted the motor cortex (brain region that controls intentional movement), but there is evidence that the cerebellum - which helps control gait and balance, is connected to several other brain areas, and is easily stimulated with tDCS - may be a likely location to further optimize walking and balance in PD. There is also evidence that certain electrodes placements may be better than others. Thus, the purpose of this study is to determine the effects of cerebellar tDCS stimulation using two different placement strategies on walking and balance in PD.

Additionally, although many tDCS devices are capable of a range of stimulation intensities (for example, 0 mA - 5 mA), the intensities currently used in most tDCS research are less than 2 mA, which is sufficient to produce measurable improvements; but, these improvements may be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate stimulation approaches were warranted. However, recent work using stimulation at higher intensities (for example, up to 4 mA) have been performed in different people and were found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, studies exploring the differences in performance between moderate (i.e., 2 mA) and higher (i.e., 4 mA) intensities are necessary to determine if increasing the intensity increases the effectiveness of the desired outcome.

Prospective participants will include 10 people with mild-moderate PD that will be recruited to complete five randomly-ordered stimulation sessions, separated by at least 5 days each. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. Data collection is expected to take 4-6 months. Each session will include walking and balance testing performed while wearing the tDCS device. Total tDCS stimulation time for each session will be 25 minutes.


Condition or disease Intervention/treatment Phase
Parkinson Disease Brain Stimulation Cerebellum Device: Transcranial direct current stimulation at 2 mA Device: Transcranial direct current stimulation at 4 mA Device: Sham transcranial direct current stimulation Not Applicable

Detailed Description:

Parkinson's disease (PD) is the second most common neurodegenerative disorder and affects approximately 1 million people in the United States with total annual costs approaching 11 billion dollars. The most common symptoms of PD are tremor, stiffness, slowness, and trouble with balance/walking, which lead to severe impairments in performing activities of daily living. Current medical and surgical treatments for PD are either only mildly effective, expensive, or associated with a variety of side-effects. Therefore, the development of practical and effective add-ons to current therapeutic treatment approaches would have many benefits. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can affect brain activity and can help make long-term brain changes to improve functions like walking and balance. While a few initial research studies and review articles involving tDCS have concluded that tDCS may improve PD walking and balance, many results are not meaningful in real life and several crucial issues still prevent tDCS from being a useful add-on intervention in PD. These include the selection of stimulation sites (brain regions stimulated) and tDCS electrode placement. Most studies have targeted the motor cortex (brain region that controls intentional movement), but there is evidence that the cerebellum - which helps control gait and balance, is connected to several other brain areas, and is easily stimulated with tDCS - may be a likely location to further optimize walking and balance in PD. There is also evidence that certain electrodes placements may be better than others. Thus, the purpose of this study is to determine the effects of cerebellar tDCS stimulation using two different placement strategies on walking and balance in PD.

Additionally, although many tDCS devices are capable of a range of stimulation intensities (for example, 0 mA - 5 mA), the intensities currently used in most tDCS research are less than 2 mA, which is sufficient to produce measurable improvements; but, these improvements may be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate stimulation approaches were warranted. However, recent work using stimulation at higher intensities (for example, up to 4 mA) have been performed in different people and were found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, studies exploring the differences in performance between moderate (i.e., 2 mA) and higher (i.e., 4 mA) intensities are necessary to determine if increasing the intensity increases the effectiveness of the desired outcome.

Prospective participants will include 10 people with mild-moderate PD that will be recruited to complete five randomly-ordered stimulation sessions (baseline/SHAM, unilateral tDCS montage at 2 mA, unilateral tDCS montage at 4 mA, bilateral tDCS montage at 2 mA, and bilateral montage at 4 mA), separated by at least 5 days. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. Data collection is expected to take 4-6 months. Each session will include gait (30-meter walk test [30mWT], 6-minute walk test [6MWT], Timed Up and Go [TUG]) and balance testing (standing on a force platform with either a firm surface or a foam surface) performed in conjunction with one of the five randomly-ordered stimulation conditions (SHAM, unilateral 2 mA, unilateral 4 mA, bilateral 2 mA, and bilateral 4 mA). Total tDCS stimulation time for each session will be 25 minutes. Gait characteristics (i.e., gait speed, stride length, step length, toe-off angle, etc.) and distance walked during the 30mWT and 6MWT will also be determined with inertial sensors (OPAL motion sensors).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Participants will be blind to the different stimulation intensities (sham, 2 mA, 4 mA)
Primary Purpose: Treatment
Official Title: Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham
50% of participants will have a unilateral cerebellar montage with the anode (active electrode) three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode (return electrode) on the ipsilateral cheek. 50% of participants will have a bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is turned (2 mA) on for the 30 seconds at the beginning and the end of the trial, but it turned to 0 mA in the intervening time.
Device: Sham transcranial direct current stimulation
Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.
Other Name: Sham tDCS

Experimental: Unilateral, 2 mA
A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time.
Device: Transcranial direct current stimulation at 2 mA
Uses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Other Name: tDCS

Experimental: Bilateral, 2 mA
Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time.
Device: Transcranial direct current stimulation at 2 mA
Uses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Other Name: tDCS

Experimental: Unilateral, 4 mA
A unilateral cerebellar montage with the anode three cm lateral to the inion on the side ipsilateral to the more PD-affected side and the cathode on the ipsilateral cheek. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time.
Device: Transcranial direct current stimulation at 4 mA
Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Other Name: tDCS

Experimental: Bilateral, 4 mA
Bilateral cerebellar tDCS will have both electrodes placed 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the less PD-affected side. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time.
Device: Transcranial direct current stimulation at 4 mA
Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Other Name: tDCS




Primary Outcome Measures :
  1. Time to complete the fast 30 meter walk test [ Time Frame: Through study completion, up to 6 months ]
    Walk as fast and as safe as possible over 30 meter

  2. Distance walked in the 6 Minute Walk Test [ Time Frame: Through study completion, up to 6 months ]
    Walk back and forth between two markers spaced 30 meters apart for six minutes

  3. Time to complete the Timed Up and Go test [ Time Frame: Through study completion, up to 6 months ]
    From a seated position, stand up, walk 5 meters, turn around, walk back, and sit back down in the chair.

  4. Movement of the center of pressure (2D; forward-backward, left-right) while standing on a firm surface (force platform) for 1 minute [ Time Frame: Through study completion, up to 6 months ]
    Stand as still as possible on a firm surface for 1 minute with the eyes open. Calculate the area of an ellipse that contains 95% of the 2D trace of the center of pressure movement.

  5. Movement of the center of pressure (2D; forward-backward, left-right) while standing on a foam surface (6 cm foam pad placed on top of force platform) for 1 minute [ Time Frame: Through study completion, up to 6 months ]
    Stand as still as possible on a foam surface for 1 minute with the eyes open. Calculate the area of an ellipse that contains 95% of the 2D trace of the center of pressure movement.

  6. Movement of the center of pressure (1D; forward-backward) while standing on a firm surface for 1 minute [ Time Frame: Through study completion, up to 6 months ]
    Stand as still as possible on a force platform for 1 minute with the eyes open. Calculate the velocity of the center of pressure movement in the forward-backward direction.

  7. Movement of the center of pressure (1D; forward-backward) while standing on a foam surface for 1 minute [ Time Frame: Through study completion, up to 6 months ]
    Stand as still as possible on a foam surface for 1 minute with the eyes open. Calculate the velocity of the center of pressure movement in the forward-backward direction.

  8. Movement of the center of pressure (1D; left-right) while standing on a firm surface for 1 minute [ Time Frame: Through study completion, up to 6 months ]
    Stand as still as possible on a force platform for 1 minute with the eyes open. Calculate the velocity of the center of pressure movement in the left-right direction.

  9. Movement of the center of pressure (1D; left-right) while standing on a foam surface for 1 minute [ Time Frame: Through study completion, up to 6 months ]
    Stand as still as possible on a foam surface for 1 minute with the eyes open. Calculate the velocity of the center of pressure movement in the left-right direction.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Adult (50-90 yrs) with a positive diagnosis of Parkinson's disease from a movement disorder specialist
  • 2) an unchanged regimen of dopaminergic medication for at least the last 3 months
  • 3) able to independently walk for 6 min
  • 4) without other chronic psychiatric or medical conditions
  • 5) not taking any psychoactive medications

Exclusion Criteria:

  • 1) pregnant
  • 2) known holes or fissures in the skull
  • 3) metallic objects or implanted devices in the skull (e.g., metal plate, deep brain stimulator)
  • 4) current or previous injuries or surgeries that cause unusual gait
  • 5) score less than 24 or 17 on the Montreal Cognitive Assessment or telephone-Montreal Cognitive Assessment, respectively
  • 6) experience freezing of gait
  • 7) a diagnosis of dementia or other neurodegenerative diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046055


Contacts
Layout table for location contacts
Contact: Craig D Workman, PhD 3194670746 craig-workman@uiowa.edu

Locations
Layout table for location information
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Craig D Workman, PhD    319-467-0746    craig-workman@uiowa.edu   
Principal Investigator: Craig D Workman, PhD         
Sponsors and Collaborators
Craig Workman
Investigators
Layout table for investigator information
Principal Investigator: Craig D Workman, PhD University of Iowa

Layout table for additonal information
Responsible Party: Craig Workman, Postdoctoral Scholar, University of Iowa
ClinicalTrials.gov Identifier: NCT04046055     History of Changes
Other Study ID Numbers: 201906759
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Craig Workman, University of Iowa:
transcranial direct current stimulation
walking
balance

Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases