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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.
Show all 11Show fewer
  • 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

Other trials in United States

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).

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 groups in NCT03638531
Study groupRoleWhat they receive
Anodal tDCSExperimentalAnodal tDCS will be applied in nine experimental sessions over a 2-week period.
Receives: Device: Anodal tDCS
SHAM tDCSSham comparatorSHAM 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted20 Aug 2018
  2. Study start30 Jul 2018
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

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 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)
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

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.

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