Parkinson DiseaseNCT04762823
Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease
A study testing Cerebellar transcranial direct current stimulation at 4 mA in people with Parkinson Disease and Healthy Adult, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy Adult
- What is being tested?
- Cerebellar 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, people with PD must meet the following criteria:
- Adult (50-90 yrs) with a positive diagnosis of Parkinson's disease from a movement disorder specialist
- On an unchanged regimen of dopaminergic medication for at least the last 3 months
- Able to independently walk for 6 min
- Without other severe chronic psychiatric or medical conditions
- Not taking any psychoactive medications
Show all 11Show fewer
- To be eligible to participate in this study, the NH subjects must meet the following criteria:
- Adult (50-90 yrs)
- Able to independently walk for 6 min
- Without any severe chronic psychiatric or medical conditions
- Not taking any psychoactive medications
Who cannot join
- An individual from either group who meets any of the following criteria will be excluded from participation in this study:
- Pregnant
- Known holes or fissures in the skull
- Metallic objects or implanted devices in the skull/head (e.g., metal plate, deep brain stimulator)
- Current or previous injuries or surgeries that cause unusual gait
- A score less than 24 or 17 on the Montreal Cognitive Assessment (MoCA) or telephone-MoCA, respectively
Show all 11Show fewer
- Additional exclusion for PwPD:
- Experience freezing of gait
- A diagnosis of dementia or other neurodegenerative diseases
- Additional exclusion for NH subjects:
- 1. A diagnosis of dementia or any neurodegenerative diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cerebellar transcranial direct current stimulation at 4 mA, Sham cerebellar transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, cerebellum, gait, balance, cognition, fatigue
- Medical subject headings
- Parkinson Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellar transcranial direct current stimulation at 4 mADevice
Also called ctDCS
Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Sham cerebellar transcranial direct current stimulationDevice
Also called Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| PD-ctDCS | Experimental | 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. Receives: Device: Cerebellar transcranial direct current stimulation at 4 mA |
| PD-sham | Sham comparator | 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. Receives: Device: Sham cerebellar transcranial direct current stimulation |
| NH-ctDCS | Active comparator | 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. Receives: Device: Cerebellar transcranial direct current stimulation at 4 mA |
| NH-sham | Sham comparator | 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. Receives: Device: Sham cerebellar transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale (MDS-UPRDS)
The scale includes four parts that assess activities of daily living (Parts I and II), a motor exam (Part III), and medication-related motor complications (Part IV). For all parts, a higher number indicates more disability.
Measured: Through study completion, up to 12 months
Fatigue Severity Scale (FSS)
A nine-item questionnaire asking subjects to rate the severity of their perceived fatigue on a 1-7 point Likert scale (a higher number means more subjective fatigue).
Measured: Through study completion, up to 12 months
Multidimensional Fatigue Inventory (MFI)
A 20-item scale evaluating five dimensions of fatigue rated on a 1-5 point Likert scale (positively phrase items reverse scored; a higher number means more fatigue).
Measured: Through study completion, up to 12 months
30-meter walk test, single-task (30mWT-ST; 2 trials)
Subjects walk at their usual/comfortable speed; walking characteristics and the time taken to complete the task are the primary outcomes (more time = worse performance)
Measured: Through study completion, up to 12 months
30-meter walk test, dual-task (30mWT-DT; 2 trials)
Same as 30mWT-ST, except the subjects perform a secondary/cognitive task during the walking. The secondary task will involve serially subtracting 7 from a randomly selected starting number (100, 125, 150, 200; won't repeat a starting number within a given session). Changes in task performance between single- and dual-task conditions represent dual-task interference.
Measured: Through study completion, up to 12 months
6-minute walk test (6MWT; 1 trial)
Subjects walk back and forth between two markers spaced 30 m apart at the usual speed. The total distance walked is the primary outcome (longer distance walked is an analog for less fatigue).
Measured: Through study completion, up to 12 months
9-hole peg test (9-HPT; two trials with each hand)
The subjects are instructed to pick up the pegs from a shallow cup one at a time, place them in the holes, and then immediately take the pegs back out of the holes one at a time. Time to put the pegs in and take them out again is recorded (more time = worse performance).
Measured: Through study completion, up to 12 months
Reaction time test (simple and choice; 1 trial each)
Simple: A white box is displayed on a computer screen. When a black X appears in the white box, the subjects need to press the computer space bar as quickly as possible. Several trials with random inter-stimulus-intervals are presented. Choice: Four white boxes are displayed on the screen. When a black X appears in one of the boxes, the subjects need to press the appropriate key (z = left-most box, x = second from left, comma (,) = third from left, and period (.) = right-most) as quickly as possible. The average reaction time is recorded (more time = worse performance).
Measured: Through study completion, up to 12 months
Flanker Inhibitory Control and Attention Test (1 trial)
On each trial, a central directional target (arrow) is flanked by similar stimuli on the left and right (five total arrows). The task is to indicate the direction of the central stimulus (i.e., the third arrow). On congruent trials, the flanker arrows face the same direction as the target. On incongruent trials, they face the opposite direction. Time to react to the different conditions is recorded (more time = worse performance).
Measured: Through study completion, up to 12 months
Trail Making Test A and B (TMT A/B; 1 trial each)
Both parts consist of 25 circles (Part A: numbered 1 - 15; Part B: numbers and letters 1- 13 and A - L). The subject draws lines connecting the numbers in ascending order (Part A: 1-2-3-4-5 etc.) and then in alternating-ascending order (Part B; e.g., 1-A-2-B-3-C, etc.) as quickly and as accurately as possible without lifting the pen/pencil off the paper. Time to complete the "trail" is recorded (more time = worse performance).
Measured: Through study completion, up to 12 months
Berg Balance Scale (BBS)
14-item scale rated on a 0 - 4 Likert scale that assesses balance performance in several dynamic and static conditions (lower score = worse balance).
Measured: Through study completion, up to 12 months
Static Posturography.
- stand on a firm surface (directly on a force platform) for 1 minute with eyes open (balance characteristics [95% confidence interval of the total 2D area explored, the center of pressure movement velocity in forward/backward and left/right directions] are the primary outcomes), 2) stand on a foam surface (6 cm foam pad placed on top of force platform) for 1 minute with eyes open (the same balance characteristics as above are the primary outcomes).
Measured: Through study completion, up to 12 months
Secondary outcomes (1)
Brain activity PET Imaging with [18F]Fluorodeoxyglucose (FDG)
Assesses resting-state brain activity by determining brain glucose usage. Involves the injection of a radioactive glucose analog that can be imaged with the PET scanner.
Measured: Through study completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Aug 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Why it stopped: The PI (Post-Doc Craig Workman) left the university.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig D Workman, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762823
- Sponsor's protocol ID
- 202007551
- Status last verified
- Jun 2022
- First submitted
- 16 Feb 2021
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04762823
- Acronym / sponsor ID
- 202007551
- Conditions
- Parkinson Disease, Healthy Adult
- Keywords
- transcranial direct current stimulation, cerebellum, gait, balance, cognition, fatigue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI (Post-Doc Craig Workman) left the university.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD-ctDCS | Experimental | Device: Cerebellar transcranial direct current stimulation at 4 mAPeople 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. |
| PD-sham | Sham comparator | Device: Sham cerebellar transcranial direct current stimulationPeople 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. |
| NH-ctDCS | Active comparator | Device: Cerebellar transcranial direct current stimulation at 4 mANeurologically 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. |
| NH-sham | Sham comparator | Device: Sham cerebellar transcranial direct current stimulationNeurologically 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- To be eligible to participate in this study, people with PD must meet the following criteria:
- Adult (50-90 yrs) with a positive diagnosis of Parkinson's disease from a movement disorder specialist
- On an unchanged regimen of dopaminergic medication for at least the last 3 months
- Able to independently walk for 6 min
- Without other severe chronic psychiatric or medical conditions
Key exclusion criteria (11 listed)
- An individual from either group who meets any of the following criteria will be excluded from participation in this study:
- Pregnant
- Known holes or fissures in the skull
- Metallic objects or implanted devices in the skull/head (e.g., metal plate, deep brain stimulator)
- Current or previous injuries or surgeries that cause unusual gait
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebellar transcranial direct current stimulation at 4 mAAlso: ctDCSUses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes. | Device | NH-ctDCS, PD-ctDCS |
| Sham cerebellar transcranial direct current stimulationAlso: ShamUses 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. | Device | NH-sham, PD-sham |
Primary outcome
Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale (MDS-UPRDS)
Time frame: Through study completion, up to 12 months
The scale includes four parts that assess activities of daily living (Parts I and II), a motor exam (Part III), and medication-related motor complications (Part IV). For all parts, a higher number indicates more disability.
Fatigue Severity Scale (FSS)
Time frame: Through study completion, up to 12 months
A nine-item questionnaire asking subjects to rate the severity of their perceived fatigue on a 1-7 point Likert scale (a higher number means more subjective fatigue).
Multidimensional Fatigue Inventory (MFI)
Time frame: Through study completion, up to 12 months
A 20-item scale evaluating five dimensions of fatigue rated on a 1-5 point Likert scale (positively phrase items reverse scored; a higher number means more fatigue).
30-meter walk test, single-task (30mWT-ST; 2 trials)
Time frame: Through study completion, up to 12 months
Subjects walk at their usual/comfortable speed; walking characteristics and the time taken to complete the task are the primary outcomes (more time = worse performance)
30-meter walk test, dual-task (30mWT-DT; 2 trials)
Time frame: Through study completion, up to 12 months
Same as 30mWT-ST, except the subjects perform a secondary/cognitive task during the walking. The secondary task will involve serially subtracting 7 from a randomly selected starting number (100, 125, 150, 200; won't repeat a starting number within a given session). Changes in task performance between single- and dual-task conditions represent dual-task interference.
6-minute walk test (6MWT; 1 trial)
Time frame: Through study completion, up to 12 months
Subjects walk back and forth between two markers spaced 30 m apart at the usual speed. The total distance walked is the primary outcome (longer distance walked is an analog for less fatigue).
9-hole peg test (9-HPT; two trials with each hand)
Time frame: Through study completion, up to 12 months
The subjects are instructed to pick up the pegs from a shallow cup one at a time, place them in the holes, and then immediately take the pegs back out of the holes one at a time. Time to put the pegs in and take them out again is recorded (more time = worse performance).
Reaction time test (simple and choice; 1 trial each)
Time frame: Through study completion, up to 12 months
Simple: A white box is displayed on a computer screen. When a black X appears in the white box, the subjects need to press the computer space bar as quickly as possible. Several trials with random inter-stimulus-intervals are presented. Choice: Four white boxes are displayed on the screen. When a black X appears in one of the boxes, the subjects need to press the appropriate key (z = left-most box, x = second from left, comma (,) = third from left, and period (.) = right-most) as quickly as possible. The average reaction time is recorded (more time = worse performance).
Flanker Inhibitory Control and Attention Test (1 trial)
Time frame: Through study completion, up to 12 months
On each trial, a central directional target (arrow) is flanked by similar stimuli on the left and right (five total arrows). The task is to indicate the direction of the central stimulus (i.e., the third arrow). On congruent trials, the flanker arrows face the same direction as the target. On incongruent trials, they face the opposite direction. Time to react to the different conditions is recorded (more time = worse performance).
Trail Making Test A and B (TMT A/B; 1 trial each)
Time frame: Through study completion, up to 12 months
Both parts consist of 25 circles (Part A: numbered 1 - 15; Part B: numbers and letters 1- 13 and A - L). The subject draws lines connecting the numbers in ascending order (Part A: 1-2-3-4-5 etc.) and then in alternating-ascending order (Part B; e.g., 1-A-2-B-3-C, etc.) as quickly and as accurately as possible without lifting the pen/pencil off the paper. Time to complete the "trail" is recorded (more time = worse performance).
Berg Balance Scale (BBS)
Time frame: Through study completion, up to 12 months
14-item scale rated on a 0 - 4 Likert scale that assesses balance performance in several dynamic and static conditions (lower score = worse balance).
Static Posturography.
Time frame: Through study completion, up to 12 months
1) stand on a firm surface (directly on a force platform) for 1 minute with eyes open (balance characteristics [95% confidence interval of the total 2D area explored, the center of pressure movement velocity in forward/backward and left/right directions] are the primary outcomes), 2) stand on a foam surface (6 cm foam pad placed on top of force platform) for 1 minute with eyes open (the same balance characteristics as above are the primary outcomes).
1 secondary outcome
Brain activity PET Imaging with [18F]Fluorodeoxyglucose (FDG)
Time frame: Through study completion, up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig D Workman, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebellar transcranial direct current stimulation at 4 mA in people with Parkinson Disease and Healthy Adult, run by University of Iowa 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 11 inclusion and 11 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: withdrawn, as of the sponsor's last update on 28 Jun 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale (MDS-UPRDS) (time frame: Through study completion, up to 12 months). The study lists 12 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 28 Jun 2022.