Parkinson's DiseaseParkinStimNCT02125383
ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease
A study testing Active tDCS in people with Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Active tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Feb 2015
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic Parkinson's disease (PD) according to the UK PD brain bank criteria
- Hoehn and Yahr stage II-III when off anti-parkinsonian medication
- Able to provide informed consent
- Currently taking levodopa (300-800 mg per day)
- On stable regimen of anti-parkinsonian medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study
- Presence of early morning akinesia
- Naïve to tDCS.
Who cannot join
- Children will be excluded from this study due to the fact that they are unlikely to have PD
- Significant medical or psychiatric illness, significant neurological disease other than PD, metal objects and/or deep brain stimulators in the head that might pose a hazard during tDCS
- Dementia, as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- Significant depression (Geriatric Depression Scale score < 20)
- Presence of hallucinations
- Having undergone any surgical procedure for treatment of PD including deep brain stimulation (DBS), pallidotomy, thalamotomy, or other brain surgeries
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- A history of seizures
- A known history of severe sleep apnea or sleep onset insomnia
- Skin diseases that could potentially cause irritations under electrodes
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I
The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.
Read the detailed description
The clinical study will follow a counterbalanced crossover design during which subjects will undergo two separate pairs of two-consecutive-overnight sleep studies and receive anodal tDCS (active or sham) to M1. The first sleep study in each pair will acclimate subjects to the sleep laboratory and minimize "first night" effects, thus no tDCS will be applied. The second sleep study in each pair will include active or sham tDCS, presented in a pseudorandom order such that approximately half of the subjects receive active tDCS first while the other half receives sham first. The two pairs of sleep studies will be separated by one to three weeks.
- Conditions
- Parkinson's Disease
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Parkinson's disease, Transcranial direct current stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSProcedure or surgery
Anodal tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
Sham tDCSProcedure or surgery
Sham tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Receives 20 minutes of anodal tDCS three times while sleeping during the night. Receives: Procedure: Active tDCS |
| Sham tDCS | Sham comparator | Receives 20 minutes of sham tDCS three times while sleeping during the night. Receives: Procedure: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD motor scores measured by Kinesia HomeView
PD motor symptoms will be assessed for two days before (baseline) and two days after each tDCS sleep study using Kinesia HomeView. Changes for active tDCS will be compared to changes for sham tDCS.
Measured: Average change from two days before tDCS sleep study to two days after tDCS sleep study
Secondary outcomes (4)
Sleepiness
Epworth Sleepiness Scale
Measured: Average change from two days before tDCS sleep study to two days after tDCS sleep study
tDCS sensations
Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study.
Measured: Day after tDCS sleep studies
Motor scores measured by the Unified Parkinson's Disease Rating Scale
Measured: Average change from day before tDCS sleep study to day after tDCS sleep study
Overnight Polysomnography
Polysomnography parameters will be compared during the active and sham tDCS sleep studies.
Measured: During each sleep study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Dustin A Heldman, Ph.D., Principal investigator, Great Lakes NeuroTechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125383
- Sponsor's protocol ID
- 1R43NS077652-01A1
- Other IDs
- 1R43NS077652-01A1
- Acronym
- ParkinStim
- Status last verified
- Mar 2015
- First submitted
- 25 Apr 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I
- ClinicalTrials.gov ID
- NCT02125383
- Acronym / sponsor ID
- ParkinStim / 1R43NS077652-01A1
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Apr 2014 (estimated)
- 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 purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.
Detailed description
The clinical study will follow a counterbalanced crossover design during which subjects will undergo two separate pairs of two-consecutive-overnight sleep studies and receive anodal tDCS (active or sham) to M1. The first sleep study in each pair will acclimate subjects to the sleep laboratory and minimize "first night" effects, thus no tDCS will be applied. The second sleep study in each pair will include active or sham tDCS, presented in a pseudorandom order such that approximately half of the subjects receive active tDCS first while the other half receives sham first. The two pairs of sleep studies will be separated by one to three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Procedure: Active tDCSReceives 20 minutes of anodal tDCS three times while sleeping during the night. |
| Sham tDCS | Sham comparator | Procedure: Sham tDCSReceives 20 minutes of sham tDCS three times while sleeping during the night. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of idiopathic Parkinson's disease (PD) according to the UK PD brain bank criteria
- Hoehn and Yahr stage II-III when off anti-parkinsonian medication
- Able to provide informed consent
- Currently taking levodopa (300-800 mg per day)
- On stable regimen of anti-parkinsonian medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study
Key exclusion criteria (9 listed)
- Children will be excluded from this study due to the fact that they are unlikely to have PD
- Significant medical or psychiatric illness, significant neurological disease other than PD, metal objects and/or deep brain stimulators in the head that might pose a hazard during tDCS
- Dementia, as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- Significant depression (Geriatric Depression Scale score < 20)
- Presence of hallucinations
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 |
|---|---|---|
| Active tDCSAnodal tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour | Procedure or surgery | Active tDCS |
| Sham tDCSSham tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour | Procedure or surgery | Sham tDCS |
Primary outcome
PD motor scores measured by Kinesia HomeView
Time frame: Average change from two days before tDCS sleep study to two days after tDCS sleep study
PD motor symptoms will be assessed for two days before (baseline) and two days after each tDCS sleep study using Kinesia HomeView. Changes for active tDCS will be compared to changes for sham tDCS.
4 secondary outcomes
Sleepiness
Time frame: Average change from two days before tDCS sleep study to two days after tDCS sleep study
tDCS sensations
Time frame: Day after tDCS sleep studies
Motor scores measured by the Unified Parkinson's Disease Rating Scale
Time frame: Average change from day before tDCS sleep study to day after tDCS sleep study
Overnight Polysomnography
Time frame: During each sleep study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Dustin A Heldman, Ph.D. principal investigator
Great Lakes NeuroTechnologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 10 Mar 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PD motor scores measured by Kinesia HomeView (time frame: Average change from two days before tDCS sleep study to two days after tDCS sleep study). 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 10 Mar 2015.