Parkinson DiseasetDCSNCT02453763
In Vivo Imaging of Therapeutic Electric Current Flow
An observational study of Parkinson Disease and Epilepsy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to measure current flow inside the head using magnetic resonance imaging (MRI). The data from this study will be used to map the current flow caused from the electrical stimulation inside the head. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Epilepsy, Alzheimer's Disease
- What is being tested?
- Transcranial direct current stimulation and MRI
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 6 Jul 2017
- Phase
- Observational
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 24 normal adult subjects will be assessed.
Who may be able to join
- right handed (as determined by the Edinburgh battery),
- English as native language.
Who cannot join
- appreciable deficits in hearing,
- appreciable problems with articulation,
- appreciable accent schizophrenia, bipolar disorder, or major depression,
- any neurological disorder associated with cognitive impairment or neuroanatomic abnormality,
- language-based learning disorder,
- any implanted metal device (precludes use of tDCS), any implanted cardiac pacemaker,
Show all 9Show fewer
- dementia or mini-mental state exam,
- <24 estimated verbal intelligence,
- <70 active or prior history of seizure disorder, family history of seizure disorder, prescribed seizure inducing medication.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to measure current flow inside the head using magnetic resonance imaging (MRI). The data from this study will be used to map the current flow caused from the electrical stimulation inside the head. The methods develop will be used to map and better control delivery of the current for electrical stimulation to modify a psychiatric condition such as depression; or other conditions such as epilepsy, Parkinson's disease or autism.
Read the detailed description
Transcranial direct current stimulation (tDCS) and deep brain stimulation (DBS) are examples of electrical stimulation therapies that are rapidly gaining attention as means of modulating motor function, semantic processing, and executive function. Both therapies have attracted many clinical and experimental studies. tDCS has been found to have both facilitatory and inhibitory effects on the brain depending on stimulation polarity and electrode position. DBS has been thoroughly evaluated clinically for treatment of movement disorders, principally Parkinson's disease, and is extending its reach to include treatment of disorders such as focal dystonia, depression and chronic pain. While still mostly in the experimental stage, tDCS applications and acceptance are growing extremely rapidly.
Although the functional alterations associated with tDCS can be categorized without knowledge of the underlying neurophysiology, an understanding of where externally applied current actually flows in any electrical stimulation technique is crucial as a basis for understanding which brain regions, circuits, or elements are affected by these therapies, and how these changes may occur. Such knowledge will lead to a better understanding of the mechanisms underlying these therapies, and thus to more focused and effective stimulation patterns and locations. Ultimately, this will lead to more efficient and novel clinical applications.
Many studies have simulated the effects of current application in both extra- and intracranial modalities using computer simulation. Simulations will always be limited by errors in interpreting MRI data during segmentation, differences between assumed and actual electrical conductivity values, and mismatches between actual and presumed electrode locations and sizes. Thus, better methods to understand and verify current flow distributions are badly needed.
In this study a recently developed MRI-based phase imaging technique to more directly measure current densities in vivo. Unlike earlier MRI-based methods of measuring electrical current flow, the technique works without requiring subject repositioning. This methods will be validated against high-resolution subject-specific models incorporating many tissue compartments, including anisotropic white matter. Thus, a new direct measurement method against state-of-the-art modeling approaches.
- Conditions
- Parkinson Disease, Epilepsy, Alzheimer's Disease, Stroke, Autism, Depression
- Being tested
- Transcranial direct current stimulation, MRI
- Keywords
- Transcranial direct current stimulation, Noninvasive brain stimulation, Brain, Central Nervous System Diseases, Nervous System Diseases, Parkinson disease, Stroke, Epilepsy, Depression, Schizophrenia, Brain imaging, Electrical impedance tomography, Magnetic resonance electrical impedance tomography, Diffusion tensor imaging, Functional magnetic imaging, Rehabilitation
- Medical subject headings
- Parkinson Disease, Epilepsy, Alzheimer Disease, Stroke, Autistic Disorder, Depression, Schizophrenia, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called Noninvasive Brain Stimulation
All participants will receive transcranial direct current stimulation. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes.
MRIProcedure or surgery
Also called Magnetic Resonance Imaging
All participants will receive an MRI. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | All participants will receive transcranial direct current stimulation and an magnetic resonance imaging (MRI). Receives: Device: Transcranial direct current stimulation; Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI) of therapeutic current flow
The MRI will be used to measure current flow in the brain as a result of therapeutic electrical stimulation techniques by using a recently developed MRI-based phase imaging technique to more directly measure current densities in vivo.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJun 2015
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Thomas H Mareci, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453763
- Sponsor's protocol ID
- 506-2012-N
- Other IDs
- 1R21NS081646-01A1
- Acronym
- tDCS
- Status last verified
- Apr 2018
- First submitted
- 21 May 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sadleir RJ, Sajib SZ, Kim HJ, Kwon OI, Woo EJ. Simulations and phantom evaluations of magnetic resonance electrical impedance tomography (MREIT) for breast cancer detection. J Magn Reson. 2013 May;230:40-9. doi: 10.1016/j.jmr.2013.01.009. Epub 2013 Feb 4.
PubMed 23435264Meng ZJ, Sajib SZ, Chauhan M, Sadleir RJ, Kim HJ, Kwon OI, Woo EJ. Numerical simulations of MREIT conductivity imaging for brain tumor detection. Comput Math Methods Med. 2013;2013:704829. doi: 10.1155/2013/704829. Epub 2013 Apr 29.
PubMed 23737862DeMarse TB, Carney PR. Augmentation of cognitive function in epilepsy. Front Syst Neurosci. 2014 Aug 14;8:147. doi: 10.3389/fnsys.2014.00147. eCollection 2014. No abstract available.
PubMed 25177279Sadleir RJ, Vannorsdall TD, Schretlen DJ, Gordon B. Target optimization in transcranial direct current stimulation. Front Psychiatry. 2012 Oct 17;3:90. doi: 10.3389/fpsyt.2012.00090. eCollection 2012.
PubMed 23087654
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Imaging of Therapeutic Electric Current Flow
- ClinicalTrials.gov ID
- NCT02453763
- Acronym / sponsor ID
- tDCS / 506-2012-N
- Conditions
- Parkinson Disease, Epilepsy, Alzheimer's Disease, Stroke, Autism, Depression
- Keywords
- Transcranial direct current stimulation, Noninvasive brain stimulation, Brain, Central Nervous System Diseases, Nervous System Diseases, Parkinson disease, Stroke, Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Arizona State University, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2015
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 25 May 2015 (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 research study is to measure current flow inside the head using magnetic resonance imaging (MRI). The data from this study will be used to map the current flow caused from the electrical stimulation inside the head. The methods develop will be used to map and better control delivery of the current for electrical stimulation to modify a psychiatric condition such as depression; or other conditions such as epilepsy, Parkinson's disease or autism.
Detailed description
Transcranial direct current stimulation (tDCS) and deep brain stimulation (DBS) are examples of electrical stimulation therapies that are rapidly gaining attention as means of modulating motor function, semantic processing, and executive function. Both therapies have attracted many clinical and experimental studies. tDCS has been found to have both facilitatory and inhibitory effects on the brain depending on stimulation polarity and electrode position. DBS has been thoroughly evaluated clinically for treatment of movement disorders, principally Parkinson's disease, and is extending its reach to include treatment of disorders such as focal dystonia, depression and chronic pain. While still mostly in the experimental stage, tDCS applications and acceptance are growing extremely rapidly.
Although the functional alterations associated with tDCS can be categorized without knowledge of the underlying neurophysiology, an understanding of where externally applied current actually flows in any electrical stimulation technique is crucial as a basis for understanding which brain regions, circuits, or elements are affected by these therapies, and how these changes may occur. Such knowledge will lead to a better understanding of the mechanisms underlying these therapies, and thus to more focused and effective stimulation patterns and locations. Ultimately, this will lead to more efficient and novel clinical applications.
Many studies have simulated the effects of current application in both extra- and intracranial modalities using computer simulation. Simulations will always be limited by errors in interpreting MRI data during segmentation, differences between assumed and actual electrical conductivity values, and mismatches between actual and presumed electrode locations and sizes. Thus, better methods to understand and verify current flow distributions are badly needed.
In this study a recently developed MRI-based phase imaging technique to more directly measure current densities in vivo. Unlike earlier MRI-based methods of measuring electrical current flow, the technique works without requiring subject repositioning. This methods will be validated against high-resolution subject-specific models incorporating many tissue compartments, including anisotropic white matter. Thus, a new direct measurement method against state-of-the-art modeling approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | – | Device: Transcranial direct current stimulation, Procedure: MRIAll participants will receive transcranial direct current stimulation and an magnetic resonance imaging (MRI). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 24 normal adult subjects will be assessed.
Key inclusion criteria (2 listed)
- right handed (as determined by the Edinburgh battery),
- English as native language.
Key exclusion criteria (9 listed)
- appreciable deficits in hearing,
- appreciable problems with articulation,
- appreciable accent schizophrenia, bipolar disorder, or major depression,
- any neurological disorder associated with cognitive impairment or neuroanatomic abnormality,
- language-based learning disorder,
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 |
|---|---|---|
| Transcranial direct current stimulationAlso: Noninvasive Brain StimulationAll participants will receive transcranial direct current stimulation. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes. | Device | Transcranial direct current stimulation |
| MRIAlso: Magnetic Resonance ImagingAll participants will receive an MRI. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes. | Procedure or surgery | Transcranial direct current stimulation |
Primary outcome
Magnetic Resonance Imaging (MRI) of therapeutic current flow
Time frame: Day 1
The MRI will be used to measure current flow in the brain as a result of therapeutic electrical stimulation techniques by using a recently developed MRI-based phase imaging technique to more directly measure current densities in vivo.
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 5 Apr 2018.
- Background: PubMed 23435264Sadleir RJ, Sajib SZ, Kim HJ, Kwon OI, Woo EJ. Simulations and phantom evaluations of magnetic resonance electrical impedance tomography (MREIT) for breast cancer detection. J Magn Reson. 2013 May;230:40-9. doi: 10.1016/j.jmr.2013.01.009. Epub 2013 Feb 4.
- Background: PubMed 23737862Meng ZJ, Sajib SZ, Chauhan M, Sadleir RJ, Kim HJ, Kwon OI, Woo EJ. Numerical simulations of MREIT conductivity imaging for brain tumor detection. Comput Math Methods Med. 2013;2013:704829. doi: 10.1155/2013/704829. Epub 2013 Apr 29.
- Background: PubMed 25177279DeMarse TB, Carney PR. Augmentation of cognitive function in epilepsy. Front Syst Neurosci. 2014 Aug 14;8:147. doi: 10.3389/fnsys.2014.00147. eCollection 2014. No abstract available.
- Results publication: PubMed 23087654Sadleir RJ, Vannorsdall TD, Schretlen DJ, Gordon B. Target optimization in transcranial direct current stimulation. Front Psychiatry. 2012 Oct 17;3:90. doi: 10.3389/fpsyt.2012.00090. eCollection 2012.
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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.
Thomas H Mareci, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Epilepsy, run by University of Florida 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 2 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 5 Apr 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. 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?
Magnetic Resonance Imaging (MRI) of therapeutic current flow (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453763, which also lists 4 linked publications.
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 5 Apr 2018.