Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease

NCT04046055 | Completed Results FDA Device

• 1 other identifier: 201906759
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Brain Stimulation; Cerebellum

Keywords

transcranial direct current stimulation; walking; balance

Outcome Measures

Primary Outcomes (4)

• Speed Walked During 30 Meter Walk Test

  Walk as fast and as safe as possible over 30 meter

  10 minutes

• Time to Complete the Timed Up and Go Test

  From a seated position, stand up, walk 5 meters, turn around, walk back, and sit back down in the chair.

  10 minutes

• Movement of the Center of Pressure (2D; Forward-backward, Left-right) While Standing on a Firm Surface (Force Platform) for 1 Minute

  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.

  1 minute

• 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

  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.

  1 minute

Secondary Outcomes (4)

• Movement of the Center of Pressure (1D; Forward-backward) While Standing on a Firm Surface (Force Platform) for 1 Minute

  1 minute

• Movement of the Center of Pressure (1D; Left-Right) While Standing on a Firm Surface (Force Platform) for 1 Minute

  1 minute

• Movement of the Center of Pressure (1D; Forward-backward) While Standing on a Foam Surface (6 cm Foam Pad Placed on Top of Force Platform) for 1 Minute

  1 minute

• Movement of the Center of Pressure (1D; Left-Right) While Standing on a Foam Surface (6 cm Foam Pad Placed on Top of Force Platform) for 1 Minute

  1 minute

Study Arms (1)

Sham and Experimental Sessions

EXPERIMENTAL

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. A unilateral cerebellar montage will be applied. tDCS intensity will be 2 mA. Bilateral cerebellar tDCS will be applied. tDCS intensity will be 2 mA. A unilateral cerebellar montage will be applied. tDCS intensity will be 4 mA. Bilateral cerebellar tDCS will be applied. tDCS intensity will be 4 mA.

Device: Transcranial direct current stimulation at 2 mA; Device: Transcranial direct current stimulation at 4 mA; Device: Sham transcranial direct current stimulation

Interventions

Transcranial direct current stimulation at 2 mA DEVICE

Uses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.

Also known as: tDCS

Sham and Experimental Sessions

Transcranial direct current stimulation at 4 mA DEVICE

Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.

Also known as: tDCS

Sham and Experimental Sessions

Sham transcranial direct current stimulation DEVICE

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.

Also known as: Sham tDCS

Sham and Experimental Sessions

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Thorsten Rudroff: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Craig D. Workman
• Organization: University of Iowa

craig-workman@uiowa.edu

319-467-0746

Study Officials

• Thorsten Rudroff, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be blind to the different stimulation intensities (sham, 2 mA, 4 mA)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants completed all 5 randomly ordered tDCS sessions (sham, unilateral 2 mA, unilateral4 mA, bilateral 2 mA, and bilateral 4 mA.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: December 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 10, 2022
• Results First Posted: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)