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Parkinson DiseaseNCT04046055

Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease

A study testing Transcranial direct current stimulation at 2 mA and Transcranial direct current stimulation at 4 mA in people with Parkinson Disease and Brain Stimulation, run by Thorsten Rudroff at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Parkinson Disease, Brain Stimulation, Cerebellum
What is being tested?
Transcranial direct current stimulation at 2 mA and Transcranial direct current stimulation at 4 mA
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7 participants
Where
1 siteUnited States
Study dates
1 Dec 2019to 1 Apr 2020
Phase
Interventional
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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.

Read the 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).

Being tested
Transcranial direct current stimulation at 2 mA, Transcranial direct current stimulation at 4 mA, Sham transcranial direct current stimulation
Keywords
transcranial direct current stimulation, walking, balance
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulation at 2 mADevice

    Also called tDCS

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

  • Transcranial direct current stimulation at 4 mADevice

    Also called tDCS

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

  • Sham transcranial direct current stimulationDevice

    Also called Sham tDCS

    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.

Study groups in NCT04046055
Study groupRoleWhat they receive
Sham and Experimental SessionsExperimental50% 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.
Receives: Device: Transcranial direct current stimulation at 2 mA; Device: Transcranial direct current stimulation at 4 mA; Device: Sham transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speed Walked During 30 Meter Walk Test

    Walk as fast and as safe as possible over 30 meter

    Measured: 10 minutes

  2. 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.

    Measured: 10 minutes

  3. 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.

    Measured: 1 minute

  4. 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.

    Measured: 1 minute

Secondary outcomes (4)
  1. Movement of the Center of Pressure (1D; Forward-backward) 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.

    Measured: 1 minute

  2. Movement of the Center of Pressure (1D; 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.

    Measured: 1 minute

  3. 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

    Stand as still as possible on a foam surface for 1 minute with the eyes open.

    Measured: 1 minute

  4. 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

    Stand as still as possible on a foam surface for 1 minute with the eyes open.

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start1 Dec 2019
  3. Primary completion1 Apr 2020
  4. Study completion1 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
All participants completed all 5 randomly ordered tDCS sessions (sham, unilateral 2 mA, unilateral4 mA, bilateral 2 mA, and bilateral 4 mA.
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04046055
Sponsor's protocol ID
201906759
Status last verified
Oct 2022
First submitted
2 Aug 2019
Last updated
10 Nov 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation at 2 mA and Transcranial direct current stimulation at 4 mA in people with Parkinson Disease and Brain Stimulation, run by Thorsten Rudroff 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 5 inclusion and 7 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 10 Nov 2022. 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 10 Nov 2022). 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?

Speed Walked During 30 Meter Walk Test (time frame: 10 minutes). The study lists 4 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 10 Nov 2022.

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