HealthyPhase 1NCT00424216
Direct Current Brain Polarization of the Frontal Lobes
A Phase 1 study testing DC Polarization in people with Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will explore what effects, if any, direct current (DC) brain polarization may produce on mental processes, such as attention, reaction time, working memory, speed of information processing and mood or emotional states. In DC brain polarization, a very weak electrical current is applied to the head. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DC Polarization
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2007to 23 Dec 2008
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers over age 18. Pregnant women are eligible.
Who cannot join
- Presence of metal in the cranial cavity or any holes in the skull due to trauma or surgery.
- Uncontrolled medical problems, such as diabetes mellitus, hypertension, airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
- Broken skin in the area of the electrodes.
- Any history of a neurological or psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Direct Current Brain Polarization of Bilateral Prefrontal Cortex
This study will explore what effects, if any, direct current (DC) brain polarization may produce on mental processes, such as attention, reaction time, working memory, speed of information processing and mood or emotional states. In DC brain polarization, a very weak electrical current is applied to the head. This technique has been used for many years on patients and healthy people with no known serious side effects. Studies have shown that DC polarization can temporarily improve people's ability to think of certain words. To determine if DC polarization can be used as a treatment for certain types of brain disorders, its possible effects on mood and other mental abilities must be determined.
Healthy normal volunteers over age 18 may be eligible for this study.
Read more
In each of three 1.5-hour sessions scheduled a day apart, participants complete the tasks listed below to determine the effects of polarization. For each session, electrodes are placed on the head, arm, and hand. One set of electrodes is for brain stimulation; the second set is used to measure the amount of skin moisture on the hand. The participants' tasks are to:
- Push a button on a keyboard when they see a specific item.
- Circle a number or make a mark on a line to indicate how much they feel a particular emotion or sensation at that time.
- Answer questions about themselves, or their opinions on certain topics.
- Look at several pictures and say how emotional they think they are.
- Read about an imaginary situation and say what they would do in that situation.
- Choose between decks of cards to try to win money.
- Compare the angles of lines.
- Identify smells, using a scratch and sniff test.
- At the end of the session, say how they are feeling.
Participants are called by phone on the day after each session to see how they are feeling.
Read the detailed description
Objective: The principal objective is to establish the safety and feasibility of bilateral direct current (DC) polarization of the frontal lobes, which may be a useful modality for treatment of frontal lobe cognitive or behavioral deficits. Our secondary objective is to gather preliminary data on whether DC can modulate cognitive and emotion-related functions of the frontal lobes in healthy individuals. Study population: 25 healthy volunteers between the ages of 18 and 80 will be enrolled. Design: The study is a double-blind crossover study with three arms: anodal polarization, cathodal polarization, and sham treatment. Outcome Measures: The primary outcome measures are 1) cognitive function as measured with the CalCAP battery or 2) emotional state as measured with the Profile of Mood States. Secondary outcome measures include tests of emotion-based decision making and social cognition.
- Conditions
- Healthy
- Being tested
- DC Polarization
- Keywords
- Mood, Emotion, Judgment, Cortex, Brain Stimulation, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC PolarizationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure significant changes in psychomotor and cognitive function with the CalCAP battery or adverse changes in mood as measured by the Profile of Mood States.
Secondary outcomes (1)
Screen for other cognitive, emotional, and perceptual changes using standardized and validated neuropsychological tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study start11 Jan 2007
- Study completion23 Dec 2008
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.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 25 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424216
- Sponsor's protocol ID
- 070066
- Other IDs
- 07-N-0066
- Status last verified
- 23 Dec 2008
- First submitted
- 17 Jan 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bechara A, Tranel D, Damasio H, Damasio AR. Failure to respond autonomically to anticipated future outcomes following damage to prefrontal cortex. Cereb Cortex. 1996 Mar-Apr;6(2):215-25. doi: 10.1093/cercor/6.2.215.
PubMed 8670652BINDMAN LJ, LIPPOLD OC, REDFEARN JW. Long-lasting changes in the level of the electrical activity of the cerebral cortex produced bypolarizing currents. Nature. 1962 Nov 10;196:584-5. doi: 10.1038/196584a0. No abstract available.
PubMed 13968314CREUTZFELDT OD, FROMM GH, KAPP H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52. doi: 10.1016/0014-4886(62)90056-0. No abstract available.
PubMed 13882165
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Current Brain Polarization of Bilateral Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT00424216
- Acronym / sponsor ID
- 070066
- Conditions
- Healthy
- Keywords
- Mood, Emotion, Judgment, Cortex, Brain Stimulation, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Jan 2007
- Study completion
- 23 Dec 2008
- First posted
- 18 Jan 2007 (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 explore what effects, if any, direct current (DC) brain polarization may produce on mental processes, such as attention, reaction time, working memory, speed of information processing and mood or emotional states. In DC brain polarization, a very weak electrical current is applied to the head. This technique has been used for many years on patients and healthy people with no known serious side effects. Studies have shown that DC polarization can temporarily improve people's ability to think of certain words. To determine if DC polarization can be used as a treatment for certain types of brain disorders, its possible effects on mood and other mental abilities must be determined.
Healthy normal volunteers over age 18 may be eligible for this study.
In each of three 1.5-hour sessions scheduled a day apart, participants complete the tasks listed below to determine the effects of polarization. For each session, electrodes are placed on the head, arm, and hand. One set of electrodes is for brain stimulation; the second set is used to measure the amount of skin moisture on the hand. The participants' tasks are to:
- Push a button on a keyboard when they see a specific item.
- Circle a number or make a mark on a line to indicate how much they feel a particular emotion or sensation at that time.
- Answer questions about themselves, or their opinions on certain topics.
- Look at several pictures and say how emotional they think they are.
- Read about an imaginary situation and say what they would do in that situation.
- Choose between decks of cards to try to win money.
- Compare the angles of lines.
- Identify smells, using a scratch and sniff test.
- At the end of the session, say how they are feeling.
Participants are called by phone on the day after each session to see how they are feeling.
Detailed description
Objective: The principal objective is to establish the safety and feasibility of bilateral direct current (DC) polarization of the frontal lobes, which may be a useful modality for treatment of frontal lobe cognitive or behavioral deficits. Our secondary objective is to gather preliminary data on whether DC can modulate cognitive and emotion-related functions of the frontal lobes in healthy individuals. Study population: 25 healthy volunteers between the ages of 18 and 80 will be enrolled. Design: The study is a double-blind crossover study with three arms: anodal polarization, cathodal polarization, and sham treatment. Outcome Measures: The primary outcome measures are 1) cognitive function as measured with the CalCAP battery or 2) emotional state as measured with the Profile of Mood States. Secondary outcome measures include tests of emotion-based decision making and social cognition.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers over age 18. Pregnant women are eligible.
Key exclusion criteria (4 listed)
- Presence of metal in the cranial cavity or any holes in the skull due to trauma or surgery.
- Uncontrolled medical problems, such as diabetes mellitus, hypertension, airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
- Broken skin in the area of the electrodes.
- Any history of a neurological or psychiatric 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 |
|---|---|---|
| DC Polarization | Procedure or surgery | – |
Primary outcome
Measure significant changes in psychomotor and cognitive function with the CalCAP battery or adverse changes in mood as measured by the Profile of Mood States.
1 secondary outcome
Screen for other cognitive, emotional, and perceptual changes using standardized and validated neuropsychological tests.
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 2 Jul 2017.
- Background: PubMed 8670652Bechara A, Tranel D, Damasio H, Damasio AR. Failure to respond autonomically to anticipated future outcomes following damage to prefrontal cortex. Cereb Cortex. 1996 Mar-Apr;6(2):215-25. doi: 10.1093/cercor/6.2.215.
- Background: PubMed 13968314BINDMAN LJ, LIPPOLD OC, REDFEARN JW. Long-lasting changes in the level of the electrical activity of the cerebral cortex produced bypolarizing currents. Nature. 1962 Nov 10;196:584-5. doi: 10.1038/196584a0. No abstract available.
- Background: PubMed 13882165CREUTZFELDT OD, FROMM GH, KAPP H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52. doi: 10.1016/0014-4886(62)90056-0. No abstract available.
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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?
A Phase 1 study testing DC Polarization in people with 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 4 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 2 Jul 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Measure significant changes in psychomotor and cognitive function with the CalCAP battery or adverse changes in mood as measured by the Profile of Mood States.. 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 NCT00424216, 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 2 Jul 2017.