HealthyNCT00088569
Effect of Direct Current Polarization on Brain Function
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will test a new electrical technique called direct current (DC) polarization that is able to change brain activity in subtle ways for a short time. A recent study showed that, depending on its direction, the current could make people perform a little better or perhaps slightly worse on a test of the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 0-15 Water
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2006
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants will be right-handed volunteers, aged 20 to 70, without history of any disorder of the central nervous system.
Who cannot join
- Current serious medical or psychiatric condition of any kind.
- History of any significant trauma or medical condition affecting the brain or skull.
- History of epileptic seizure.
- Current use of neuroactive medications, medications affecting the cerebral circulation, or recreational drugs.
- Presence of metal in the head (other than dental hardware) or body, such as pacemakers, aneurysm clips, metallic prostheses (including heart valves or cochlear implants), patches with metallic foil backing, such as nicotine patches, permanent eyeliner or shrapnel fragments.
- History of welding or metal work.
- Broken skin in the area of the stimulating electrodes.
- Pregnancy/breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Measuring the Brain Effects of DC Polarization With O-15 PET
This study will test a new electrical technique called direct current (DC) polarization that is able to change brain activity in subtle ways for a short time. A recent study showed that, depending on its direction, the current could make people perform a little better or perhaps slightly worse on a test of the function of the brain's frontal lobe. This study will use positron emission tomography (PET) scanning to examine how DC polarization affects brain activity.
Healthy volunteers between 20 and 70 years of age who are right handed and who are not taking any medications that affect the brain may be eligible for this study. Candidates are screened with a brief medical history and neurological evaluation.
Read more
Participants have a PET scan on three different days at least 3 days apart. Each scanning session takes 2-1/2 to 3 hours. For the scan, radioactive water is injected into the body through a vein. Subjects lie on a bed that slides in and out of the doughnut-shaped scanner, with their head held from the back by a padded holder and in front by a custom-molded plastic mask with holes for the eyes, nose, and mouth. DC electrodes made of wet sponges are placed on the right side of the head and over the left eye and are held in place with elastic bandages.
Three kinds of DC polarization are tested. In two tests the current is the same, but in opposite directions. The third is a sham (placebo) condition with no current delivered. Each of the three scans is separated by at least 3 days. On each day, a series of scans is done in a single session. Before each injection of tracer, the DC current is turned on. This may cause a tingling or slight burning on the skin under the electrodes, which disappears when the current is turned off. In each session, the subject receives 16 injections of tracer about 8 minutes apart, with DC polarization turned on for 4 out of the 8 minutes.
During most of the 8-minute periods, subjects are shown a pattern of dots about every 2 seconds. Sometimes the subject just looks at the patterns, and sometimes subjects are asked to push a button corresponding to the pattern they saw just before the current one. Sometimes they will be asked to push a button corresponding to the pattern that came before that one and so on, up to three patterns before the current one. The task lasts for about 2 minutes each time, with time to relax in between.
Read the detailed description
Objective: The passage of weak DC currents across the head (DC polarization) is a safe and painless means of altering the activity of cortical neurons and their response to exogenous stimulation. This has been demonstrated in the human motor cortex where local anodal polarization increases, and cathodal decreases, the motor evoked potential from TMS. Recent experiments from our lab suggest that polarization may have analogous effects on the prefrontal cortex, where anodal current enhances functions including verbal fluency and psychomotor speed and cathodal current produces slight performance decrements. We are interested in the potential of DC current to enhance function in patients with frontal lobe disorders and to reduce frontal overactivation in conditions such as drug craving. Treatments that alter frontal activity may also have mood altering properties. In order to establish the principle that DC polarization is able to alter frontal lobe activity we propose to combine DC polarization with a variably loaded frontal activation task and measure regional cerebral blood flow (rCBF with H(2)(15)O positron emission tomography (PET) scanning.
Study population: Twenty healthy individuals will be studied.
Design: On three different days, participants will receive right dorsolateral prefrontal anodal, cathodal, or sham treatment. On each day, rCBF will be measured during rest without and then with treatment. Then subjects will perform the N-back task (a test of working memory) during treatment with the working memory load (N) varied between 0 and 3 items from scan to scan.
Outcome measures: Resting rCBF and the relationship between cognitive load and rCBF at the treatment site will be compared between treatments in order to look for effects on task-related activation and performance.
- Conditions
- Healthy
- Being tested
- 0-15 Water
- Keywords
- Frontal Lobe, Working Memory, Treatment, Transcranial, Electrical, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0-15 WaterDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2004 (estimated)
- Study startJul 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088569
- Sponsor's protocol ID
- 040220
- Other IDs
- 04-N-0220
- Status last verified
- Jun 2006
- First submitted
- 29 Jul 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Antal A, Kincses TZ, Nitsche MA, Paulus W. Modulation of moving phosphene thresholds by transcranial direct current stimulation of V1 in human. Neuropsychologia. 2003;41(13):1802-7. doi: 10.1016/s0028-3932(03)00181-7.
PubMed 14527543Antal A, Kincses TZ, Nitsche MA, Paulus W. Manipulation of phosphene thresholds by transcranial direct current stimulation in man. Exp Brain Res. 2003 Jun;150(3):375-8. doi: 10.1007/s00221-003-1459-8. Epub 2003 Apr 16.
PubMed 12698316Antal A, Kincses TZ, Nitsche MA, Bartfai O, Paulus W. Excitability changes induced in the human primary visual cortex by transcranial direct current stimulation: direct electrophysiological evidence. Invest Ophthalmol Vis Sci. 2004 Feb;45(2):702-7. doi: 10.1167/iovs.03-0688.
PubMed 14744917
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Brain Effects of DC Polarization With O-15 PET
- ClinicalTrials.gov ID
- NCT00088569
- Acronym / sponsor ID
- 040220
- Conditions
- Healthy
- Keywords
- Frontal Lobe, Working Memory, Treatment, Transcranial, Electrical, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jul 2004
- Study completion
- Jun 2006
- First posted
- 30 Jul 2004 (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.
This study will test a new electrical technique called direct current (DC) polarization that is able to change brain activity in subtle ways for a short time. A recent study showed that, depending on its direction, the current could make people perform a little better or perhaps slightly worse on a test of the function of the brain's frontal lobe. This study will use positron emission tomography (PET) scanning to examine how DC polarization affects brain activity.
Healthy volunteers between 20 and 70 years of age who are right handed and who are not taking any medications that affect the brain may be eligible for this study. Candidates are screened with a brief medical history and neurological evaluation.
Participants have a PET scan on three different days at least 3 days apart. Each scanning session takes 2-1/2 to 3 hours. For the scan, radioactive water is injected into the body through a vein. Subjects lie on a bed that slides in and out of the doughnut-shaped scanner, with their head held from the back by a padded holder and in front by a custom-molded plastic mask with holes for the eyes, nose, and mouth. DC electrodes made of wet sponges are placed on the right side of the head and over the left eye and are held in place with elastic bandages.
Three kinds of DC polarization are tested. In two tests the current is the same, but in opposite directions. The third is a sham (placebo) condition with no current delivered. Each of the three scans is separated by at least 3 days. On each day, a series of scans is done in a single session. Before each injection of tracer, the DC current is turned on. This may cause a tingling or slight burning on the skin under the electrodes, which disappears when the current is turned off. In each session, the subject receives 16 injections of tracer about 8 minutes apart, with DC polarization turned on for 4 out of the 8 minutes.
During most of the 8-minute periods, subjects are shown a pattern of dots about every 2 seconds. Sometimes the subject just looks at the patterns, and sometimes subjects are asked to push a button corresponding to the pattern they saw just before the current one. Sometimes they will be asked to push a button corresponding to the pattern that came before that one and so on, up to three patterns before the current one. The task lasts for about 2 minutes each time, with time to relax in between.
Detailed description
Objective: The passage of weak DC currents across the head (DC polarization) is a safe and painless means of altering the activity of cortical neurons and their response to exogenous stimulation. This has been demonstrated in the human motor cortex where local anodal polarization increases, and cathodal decreases, the motor evoked potential from TMS. Recent experiments from our lab suggest that polarization may have analogous effects on the prefrontal cortex, where anodal current enhances functions including verbal fluency and psychomotor speed and cathodal current produces slight performance decrements. We are interested in the potential of DC current to enhance function in patients with frontal lobe disorders and to reduce frontal overactivation in conditions such as drug craving. Treatments that alter frontal activity may also have mood altering properties. In order to establish the principle that DC polarization is able to alter frontal lobe activity we propose to combine DC polarization with a variably loaded frontal activation task and measure regional cerebral blood flow (rCBF with H(2)(15)O positron emission tomography (PET) scanning.
Study population: Twenty healthy individuals will be studied.
Design: On three different days, participants will receive right dorsolateral prefrontal anodal, cathodal, or sham treatment. On each day, rCBF will be measured during rest without and then with treatment. Then subjects will perform the N-back task (a test of working memory) during treatment with the working memory load (N) varied between 0 and 3 items from scan to scan.
Outcome measures: Resting rCBF and the relationship between cognitive load and rCBF at the treatment site will be compared between treatments in order to look for effects on task-related activation and performance.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be right-handed volunteers, aged 20 to 70, without history of any disorder of the central nervous system.
Key exclusion criteria (8 listed)
- Current serious medical or psychiatric condition of any kind.
- History of any significant trauma or medical condition affecting the brain or skull.
- History of epileptic seizure.
- Current use of neuroactive medications, medications affecting the cerebral circulation, or recreational drugs.
- Presence of metal in the head (other than dental hardware) or body, such as pacemakers, aneurysm clips, metallic prostheses (including heart valves or cochlear implants), patches with metallic foil backing, such as nicotine patches, permanent eyeliner or shrapnel fragments.
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 |
|---|---|---|
| 0-15 Water | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 14527543Antal A, Kincses TZ, Nitsche MA, Paulus W. Modulation of moving phosphene thresholds by transcranial direct current stimulation of V1 in human. Neuropsychologia. 2003;41(13):1802-7. doi: 10.1016/s0028-3932(03)00181-7.
- Background: PubMed 12698316Antal A, Kincses TZ, Nitsche MA, Paulus W. Manipulation of phosphene thresholds by transcranial direct current stimulation in man. Exp Brain Res. 2003 Jun;150(3):375-8. doi: 10.1007/s00221-003-1459-8. Epub 2003 Apr 16.
- Background: PubMed 14744917Antal A, Kincses TZ, Nitsche MA, Bartfai O, Paulus W. Excitability changes induced in the human primary visual cortex by transcranial direct current stimulation: direct electrophysiological evidence. Invest Ophthalmol Vis Sci. 2004 Feb;45(2):702-7. doi: 10.1167/iovs.03-0688.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 1 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088569, which also lists 3 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 4 Mar 2008.