Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease

NCT ID: NCT04762823

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2022-01-01

Brief Summary

Parkinson's disease (PD) affects approximately 1 million people in the US, with annual health care costs approaching $11 billion. PD results from a loss of dopamine-producing cells in the brain. This decrease in dopamine is associated with shaking, stiffness, slowness, balance/walking problems, thinking, and fatigue which severely impair 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 therapies would have significant benefits.

Transcranial direct current stimulation (tDCS) can influence how the brain works. A review of studies concluded that, overall, tDCS improves walking and balance in people with PD (PwPD). However, these studies had mixed results. For example, most have stimulated the frontal brain areas and all have used intensities of 2 mA (milliamperes; a measure of electrical current strength) or less. However, given the vital role of the cerebellum in walking and balance, and in PD impairments, the cerebellum may represent a more effective brain target. A recent review of studies also recommended performing investigations of higher intensity tDCS (greater than 2 mA), to potentially increase stimulation efficacy. No study has investigated the effects of multiple sessions of cerebellar tDCS on gait and balance in PwPD and none have used tDCS intensities greater than 2 mA. Therefore, there is a critical need to determine if repeated sessions of cerebellar tDCS might improve walking and balance in the short- and long-term.

Conditions

Parkinson Disease; Healthy Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PD-ctDCS

People with Parkinson's disease will have both electrodes placed 1-2 cm below and 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.

Group Type: EXPERIMENTAL

Cerebellar transcranial direct current stimulation at 4 mA

Intervention Type: DEVICE

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

PD-sham

People with Parkinson's disease will have both electrodes placed 1-2 cm below and 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 on (4 mA) for 30 seconds at the beginning and the end of the trial, but it turned to 0 mA in the intervening time.

Group Type: SHAM_COMPARATOR

Sham cerebellar transcranial direct current stimulation

Intervention Type: DEVICE

Uses weak electrical current (4 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo effects or participant expectation bias.

NH-ctDCS

Neurologically healthy older adults will have both electrodes placed 1-2 cm below and 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the non-dominant 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.

Group Type: ACTIVE_COMPARATOR

Cerebellar transcranial direct current stimulation at 4 mA

Intervention Type: DEVICE

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

NH-sham

Neurologically healthy older adults will have both electrodes placed 1-2 cm below and 3 cm to either side of the inion, with the anode assigned to the most PD-affected side and the cathode assigned to the non-dominant side. Stimulation is turned on (4 mA) for 30 seconds at the beginning and the end of the trial, but it turned to 0 mA in the intervening time.

Group Type: SHAM_COMPARATOR

Sham cerebellar transcranial direct current stimulation

Intervention Type: DEVICE

Uses weak electrical current (4 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo effects or participant expectation bias.

Interventions

Cerebellar 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.

Intervention Type: DEVICE

Sham cerebellar transcranial direct current stimulation

Uses weak electrical current (4 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo effects or participant expectation bias.

Intervention Type: DEVICE

Other Intervention Names

ctDCS; Sham

Eligibility Criteria

Inclusion Criteria

To be eligible to participate in this study, people with PD must meet the following criteria:

1. Adult (50-90 yrs) with a positive diagnosis of Parkinson's disease from a movement disorder specialist

2. On an unchanged regimen of dopaminergic medication for at least the last 3 months

3. Able to independently walk for 6 min

4. Without other severe chronic psychiatric or medical conditions

5. Not taking any psychoactive medications

To be eligible to participate in this study, the NH subjects must meet the following criteria:

1. Adult (50-90 yrs)

2. Able to independently walk for 6 min

3. Without any severe chronic psychiatric or medical conditions

4. Not taking any psychoactive medications

Exclusion Criteria

An individual from either group who meets any of the following criteria will be excluded from participation in this study:

1. Pregnant

2. Known holes or fissures in the skull

3. Metallic objects or implanted devices in the skull/head (e.g., metal plate, deep brain stimulator)

4. Current or previous injuries or surgeries that cause unusual gait

5. A score less than 24 or 17 on the Montreal Cognitive Assessment (MoCA) or telephone-MoCA, respectively

Additional exclusion for PwPD:

1. Experience freezing of gait

2. A diagnosis of dementia or other neurodegenerative diseases

Additional exclusion for NH subjects:

1. A diagnosis of dementia or any neurodegenerative diseases

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig D Workman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202007551

Identifier Type: -

Identifier Source: org_study_id