Clinical trial NCT04762823: Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease
Official title: Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Healthy Adult
Keywords: transcranial direct current stimulation
cerebellum
gait
balance
cognition
fatigue
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale (MDS-UPRDS)
timeFrame: Through study completion, up to 12 months
measure: Fatigue Severity Scale (FSS)
timeFrame: Through study completion, up to 12 months
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Through study completion, up to 12 months
measure: 30-meter walk test, single-task (30mWT-ST; 2 trials)
timeFrame: Through study completion, up to 12 months
measure: 30-meter walk test, dual-task (30mWT-DT; 2 trials)
timeFrame: Through study completion, up to 12 months
measure: 6-minute walk test (6MWT; 1 trial)
timeFrame: Through study completion, up to 12 months
measure: 9-hole peg test (9-HPT; two trials with each hand)
timeFrame: Through study completion, up to 12 months
measure: Reaction time test (simple and choice; 1 trial each)
timeFrame: Through study completion, up to 12 months
measure: Flanker Inhibitory Control and Attention Test (1 trial)
timeFrame: Through study completion, up to 12 months
measure: Trail Making Test A and B (TMT A/B; 1 trial each)
timeFrame: Through study completion, up to 12 months
measure: Berg Balance Scale (BBS)
timeFrame: Through study completion, up to 12 months
measure: Static Posturography.
timeFrame: Through study completion, up to 12 months
Secondary outcomes:
measure: Brain activity PET Imaging with [18F]Fluorodeoxyglucose (FDG)
timeFrame: Through study completion, up to 12 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Craig D Workman, PhD
role: PRINCIPAL_INVESTIGATOR
References: