Parkinson's DiseaseNCT01615718
Non-invasive Neurostimulation in Parkinson's Disease
A study testing low-intensity transcranial electrical stimulation and transcranial ultrasound in people with Parkinson's Disease, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
In this study, the investigators aim to investigate the effects of non-invasive neurostimulation - low-intensity transcranial electrical stimulation in conjunction with transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- low-intensity transcranial electrical stimulation and transcranial ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation of PD diagnosis from their clinician by either a letter or verification through their medical record
- Research criteria of "possible" or "probable" PD, as defined by Gelb et al (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson Disease. Arch Neurol.1999;56:33-39)[1]
- Age 40 or over;
- Taking stable medications for at least 30 days
Who cannot join
- Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
- History of deep brain stimulation or ablation surgery, mass brain lesions;
- History of schizophrenia, schizoaffective disorder, other psychosis, episode of bipolar illness, alcohol/drug abuse within the past year;
- Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidal;
- Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc;
- Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease);
- Pregnancy.
- Epilepsy or disorders that increase likelihood of seizures including: moderate or severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolism disorders associated with seizures, and nonlacunar stroke.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02144
About this study
Official title: Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.
In this study, the investigators aim to investigate the effects of non-invasive neurostimulation - low-intensity transcranial electrical stimulation in conjunction with transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. The investigators want to see if there is a difference between active and sham stimulation on these motor symptoms.
- Conditions
- Parkinson's Disease
- Being tested
- low-intensity transcranial electrical stimulation, transcranial ultrasound
- Keywords
- noninvasive stimulation, motor function, transcranial stimulation, transcranial ultrasound, brain 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.
low-intensity transcranial electrical stimulationProcedure or surgery
Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for 20 minutes - however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.
transcranial ultrasoundProcedure or surgery
Subjects will undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active Electrical Stim/Active Ultrasound | Experimental | Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. Receives: Procedure: low-intensity transcranial electrical stimulation; Procedure: transcranial ultrasound |
| Sham Electrical Stim/Sham Ultrasound | Sham comparator | Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. Receives: Procedure: low-intensity transcranial electrical stimulation; Procedure: transcranial ultrasound |
| Active Electrical Stim/Sham Ultrasound | Active comparator | Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes. Receives: Procedure: low-intensity transcranial electrical stimulation; Procedure: transcranial ultrasound |
| Sham Electrical Stim/Active Ultrasound | Active comparator | Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. Receives: Procedure: low-intensity transcranial electrical stimulation; Procedure: transcranial ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Motor Function
We will measure motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS), bradykinesia tests and walking tests. We will assess the changes in these scales from baseline.
Measured: Measured for approximately 2 months
Secondary outcomes (2)
Safety
We will measure safety using a battery of electrophysiology, cognitive and neurological safety markers. We will use the Scales for Outcomes in PD-Cognitive (SCOPA-COg), the n-back working memory test, adverse effects questionnaire, electroencephalography (EEG) and a standardized neurological exam
Measured: Measured for approximately 2 months
Neurophysiological Changes
We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers.
Measured: Measured for approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startSep 2013
- Primary completionApr 2019
- Study completionApr 2019
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Highland Instruments, Inc.
- Responsible party
- Principal investigator, Felipe Fregni, Spaulding Rehabilitation Hospital
- Investigators
- Timothy Wagner, PhD, Principal investigator, Highland Instruments, Inc.Felipe Fregni, MD, PhD, MPH, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615718
- Sponsor's protocol ID
- 2012-p-001120
- Other IDs
- 1R44NS080632-01
- Status last verified
- Jan 2021
- First submitted
- 30 May 2012
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.
- ClinicalTrials.gov ID
- NCT01615718
- Acronym / sponsor ID
- 2012-p-001120
- Conditions
- Parkinson's Disease
- Keywords
- noninvasive stimulation, motor function, transcranial stimulation, transcranial ultrasound, brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Highland Instruments, Inc.
- Study start
- Sep 2013
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 11 Jun 2012 (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.
In this study, the investigators aim to investigate the effects of non-invasive neurostimulation - low-intensity transcranial electrical stimulation in conjunction with transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. The investigators want to see if there is a difference between active and sham stimulation on these motor symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Electrical Stim/Active Ultrasound | Experimental | Procedure: low-intensity transcranial electrical stimulation, Procedure: transcranial ultrasoundSubjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. |
| Sham Electrical Stim/Sham Ultrasound | Sham comparator | Procedure: low-intensity transcranial electrical stimulation, Procedure: transcranial ultrasoundSubjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. |
| Active Electrical Stim/Sham Ultrasound | Active comparator | Procedure: low-intensity transcranial electrical stimulation, Procedure: transcranial ultrasoundSubjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes. |
| Sham Electrical Stim/Active Ultrasound | Active comparator | Procedure: low-intensity transcranial electrical stimulation, Procedure: transcranial ultrasoundSubjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documentation of PD diagnosis from their clinician by either a letter or verification through their medical record
- Research criteria of "possible" or "probable" PD, as defined by Gelb et al (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson Disease. Arch Neurol.1999;56:33-39)[1]
- Age 40 or over;
- Taking stable medications for at least 30 days
Key exclusion criteria (8 listed)
- Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
- History of deep brain stimulation or ablation surgery, mass brain lesions;
- History of schizophrenia, schizoaffective disorder, other psychosis, episode of bipolar illness, alcohol/drug abuse within the past year;
- Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidal;
- Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc;
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 |
|---|---|---|
| low-intensity transcranial electrical stimulationSubjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for 20 minutes - however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. | Procedure or surgery | Active Electrical Stim/Active Ultrasound, Active Electrical Stim/Sham Ultrasound, Sham Electrical Stim/Active Ultrasound, Sham Electrical Stim/Sham Ultrasound |
| transcranial ultrasoundSubjects will undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes. | Procedure or surgery | Active Electrical Stim/Active Ultrasound, Active Electrical Stim/Sham Ultrasound, Sham Electrical Stim/Active Ultrasound, Sham Electrical Stim/Sham Ultrasound |
Primary outcome
Changes in Motor Function
Time frame: Measured for approximately 2 months
We will measure motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS), bradykinesia tests and walking tests. We will assess the changes in these scales from baseline.
2 secondary outcomes
Safety
Time frame: Measured for approximately 2 months
Neurophysiological Changes
Time frame: Measured for approximately 2 months
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 27 Jan 2021.
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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.
Timothy Wagner, PhD principal investigator
Highland Instruments, Inc.
Felipe Fregni, MD, PhD, MPH principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity transcranial electrical stimulation and transcranial ultrasound in people with Parkinson's Disease, run by Spaulding Rehabilitation Hospital 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 4 inclusion and 8 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 27 Jan 2021. 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?
Changes in Motor Function (time frame: Measured for approximately 2 months). 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 27 Jan 2021.