Parkinson DiseasePhase 2NCT03638531
Long- Term Transcranial Direct Current Stimulation in Parkinson's Disease
A Phase 2 study testing Anodal tDCS in people with Parkinson Disease, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The goal of the proposed research is to determine the influence of transcranial direct current stimulation (tDCS) on long-term motor learning, transfer of motor learning, and cortical function in Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 31 Dec 2020
- Phase
- Phase 2
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent.
- A clinical diagnosis of idiopathic PD.
- A stable and optimal medical regimen of anti-parkinsonian drug therapy for the duration of the study.
- Modified Hoehn and Yahr stage between 1.0 and 3.0 in the OFF state.
- Right-hand dominant and primarily right-side affected to prevent confounds due to handedness and affected side.
Who cannot join
- An uncontrolled medical condition (i.e. hypertension, diabetes, etc).
- Evidence of secondary or atypical parkinsonism as suggested by:
- History of CVA's, exposure to toxins, neuroleptics or encephalitis.
- Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy or significant orthostatic hypertension.
- Metal in the skull or the eye, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, and metal fragments in the eye, as these may make TMS and tDCS unsafe.
- An uncertainty about the presence of metal objects in a subject's body exists.
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- Hearing loss, have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures, have another neurological disorder other than a movement disorder, or have a head injury where they passed out for more than a few seconds.
- Pregnant or thought to be pregnant.
- Irrepressible dyskinesia or tremor to prevent the confound of excessive EMG during TMS testing at rest.
- Any other neurological disorders.
- Meeting of any of the TMS exclusion criteria given in international guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bigelow Health Sciences
Las Vegas, Nevada, 89154-3034
About this study
Official title: Long-Term Transcranial Direct Current Stimulation in Parkinson's Disease
The goal of the proposed research is to determine the influence of transcranial direct current stimulation (tDCS) on long-term motor learning, transfer of motor learning, and cortical function in Parkinson's disease (PD). The project comprises a 2 week training study that will involve tDCS applied during two practice motor tasks with behavioral, clinical, and physiological evaluations at baseline as well as 1, 14 and 28 days following the 2 week training and stimulation period. The findings of the proposed studies should have significant clinical significance and applications to comprehensive intervention therapy development in the treatment of PD.
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. Current medical and surgical treatment approaches for PD are either only mildly effective, expensive, or associated with a variety of side effects. Therefore, the development of practical and effective therapeutic adjuncts to current treatment approaches would have significant benefits.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability and improve motor function in healthy subjects, older adults, and in stroke. However, there are several crucial issues that currently prevents the determination of the viability of tDCS as an adjunct intervention in PD. For example, the magnitude to which tDCS may be able to improve long-term motor learning beyond what can be achieved by practice alone in PD is unknown. It is also unclear if short-term improvements in motor function induced by tDCS and measured in the OFF state in PD can be attained over the long-term in the ON state, which is necessary for real world application. In addition, it is uncertain if the effects of tDCS generalize to non-practiced tasks and to the ipsilateral, non-tDCS stimulated hand. Finally, the physiological mechanisms underlying any of these issues have not been identified because no long-term motor learning tDCS studies in PD to date have concurrently quantified behavioral, clinical, and physiological measures.
The project will be a single-center, double-blind, randomized, sham-controlled, experimental design. PD patients will practice 2 motor tasks (practice tasks) with their right (primarily affected) hand in 9 practice sessions over a 2 week period in association with either tDCS or SHAM stimulation of the left (contralateral) motor cortex. In addition, 4 testing sessions will be performed and will include a Baseline test, an end of training test (EOT), a follow up test 2 weeks after the end of training (EOT+14), and a follow up test 4 weeks after the end of training (EOT+28). The primary outcome variables will be the force error in the first practice task (precision grip task; PGT) and the stroke amplitude, stroke variability, and writing speed in the second practice task (handwriting task; HWT). The secondary outcome variables the Unified Parkinson's Disease Rating Scale (UPDRS) Part 3, the Purdue Pegboard Test (PT), and the Jebsen Taylor Hand Function Test (JTT).
- Conditions
- Parkinson Disease
- Being tested
- Anodal tDCS, SHAM tDCS
- Keywords
- tDCS, cortical excitability, motor cortex, motor learning, handwriting, micrographia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Anodal tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task).
SHAM tDCSDevice
SHAM tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task).
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Anodal tDCS will be applied in nine experimental sessions over a 2-week period. Receives: Device: Anodal tDCS |
| SHAM tDCS | Sham comparator | SHAM tDCS will be applied in nine experimental sessions over a 2-week period. Receives: Device: SHAM tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force error in the precision grip task
Changes in force error after the two week intervention
Measured: Baseline, 1 day post, 2 weeks post, 4 weeks post
Handwriting task performance
Changes in stroke amplitude, stroke variability, and writing speed after the two week intervention
Measured: Baseline, 1 day post, 2 weeks post, 4 weeks post
Secondary outcomes (3)
Transfer of motor learning
Changes in the UPDRS Motor Section Part 3 after the two week intervention
Measured: Baseline, 1 day post, 2 weeks post, 4 weeks post
Transfer of motor learning
Changes in the Purdue Pegboard Test after the two week intervention
Measured: Baseline, 1 day post, 2 weeks post, 4 weeks post
Transfer of motor learning
Changes in the Jebsen Taylor Hand Function Test after the two week intervention
Measured: Baseline, 1 day post, 2 weeks post, 4 weeks post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start30 Jul 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brach Poston, University of Nevada, Las Vegas
- Investigators
- Brach Poston, Ph.D., Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638531
- Sponsor's protocol ID
- 1002548
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Transcranial Direct Current Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03638531
- Acronym / sponsor ID
- 1002548
- Conditions
- Parkinson Disease
- Keywords
- tDCS, cortical excitability, motor cortex, motor learning, handwriting, micrographia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Aug 2018 (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.
The goal of the proposed research is to determine the influence of transcranial direct current stimulation (tDCS) on long-term motor learning, transfer of motor learning, and cortical function in Parkinson's disease (PD). The project comprises a 2 week training study that will involve tDCS applied during two practice motor tasks with behavioral, clinical, and physiological evaluations at baseline as well as 1, 14 and 28 days following the 2 week training and stimulation period. The findings of the proposed studies should have significant clinical significance and applications to comprehensive intervention therapy development in the treatment of PD.
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. Current medical and surgical treatment approaches for PD are either only mildly effective, expensive, or associated with a variety of side effects. Therefore, the development of practical and effective therapeutic adjuncts to current treatment approaches would have significant benefits.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability and improve motor function in healthy subjects, older adults, and in stroke. However, there are several crucial issues that currently prevents the determination of the viability of tDCS as an adjunct intervention in PD. For example, the magnitude to which tDCS may be able to improve long-term motor learning beyond what can be achieved by practice alone in PD is unknown. It is also unclear if short-term improvements in motor function induced by tDCS and measured in the OFF state in PD can be attained over the long-term in the ON state, which is necessary for real world application. In addition, it is uncertain if the effects of tDCS generalize to non-practiced tasks and to the ipsilateral, non-tDCS stimulated hand. Finally, the physiological mechanisms underlying any of these issues have not been identified because no long-term motor learning tDCS studies in PD to date have concurrently quantified behavioral, clinical, and physiological measures.
The project will be a single-center, double-blind, randomized, sham-controlled, experimental design. PD patients will practice 2 motor tasks (practice tasks) with their right (primarily affected) hand in 9 practice sessions over a 2 week period in association with either tDCS or SHAM stimulation of the left (contralateral) motor cortex. In addition, 4 testing sessions will be performed and will include a Baseline test, an end of training test (EOT), a follow up test 2 weeks after the end of training (EOT+14), and a follow up test 4 weeks after the end of training (EOT+28). The primary outcome variables will be the force error in the first practice task (precision grip task; PGT) and the stroke amplitude, stroke variability, and writing speed in the second practice task (handwriting task; HWT). The secondary outcome variables the Unified Parkinson's Disease Rating Scale (UPDRS) Part 3, the Purdue Pegboard Test (PT), and the Jebsen Taylor Hand Function Test (JTT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Anodal tDCSAnodal tDCS will be applied in nine experimental sessions over a 2-week period. |
| SHAM tDCS | Sham comparator | Device: SHAM tDCSSHAM tDCS will be applied in nine experimental sessions over a 2-week period. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide informed consent.
- A clinical diagnosis of idiopathic PD.
- A stable and optimal medical regimen of anti-parkinsonian drug therapy for the duration of the study.
- Modified Hoehn and Yahr stage between 1.0 and 3.0 in the OFF state.
- Right-hand dominant and primarily right-side affected to prevent confounds due to handedness and affected side.
Key exclusion criteria (11 listed)
- An uncontrolled medical condition (i.e. hypertension, diabetes, etc).
- Evidence of secondary or atypical parkinsonism as suggested by:
- Metal in the skull or the eye, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, and metal fragments in the eye, as these may make TMS and tDCS unsafe.
- An uncertainty about the presence of metal objects in a subject's body exists.
- Hearing loss, have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures, have another neurological disorder other than a movement disorder, or have a head injury where they passed out for more than a few seconds.
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 |
|---|---|---|
| Anodal tDCSAnodal tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task). | Device | Anodal tDCS |
| SHAM tDCSSHAM tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task). | Device | SHAM tDCS |
Primary outcome
Force error in the precision grip task
Time frame: Baseline, 1 day post, 2 weeks post, 4 weeks post
Changes in force error after the two week intervention
Handwriting task performance
Time frame: Baseline, 1 day post, 2 weeks post, 4 weeks post
Changes in stroke amplitude, stroke variability, and writing speed after the two week intervention
3 secondary outcomes
Transfer of motor learning
Time frame: Baseline, 1 day post, 2 weeks post, 4 weeks post
Transfer of motor learning
Time frame: Baseline, 1 day post, 2 weeks post, 4 weeks post
Transfer of motor learning
Time frame: Baseline, 1 day post, 2 weeks post, 4 weeks post
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
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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.
Brach Poston, Ph.D. principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anodal tDCS in people with Parkinson Disease, run by University of Nevada, Las Vegas 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 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: status not confirmed, as of the sponsor's last update on 19 Oct 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Force error in the precision grip task (time frame: Baseline, 1 day post, 2 weeks post, 4 weeks post). The study lists 2 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 19 Oct 2018.