Electrical Stimulation of the BrainPhase 1NCT00048698
Effects of Direct Current Brain Stimulation on Cognition
A Phase 1 study testing TMS and EEG in people with Electrical Stimulation of the Brain, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine the effects of direct current (DC) electrical polarization of the brain on thinking speed, reaction time, mood, and brain waves in healthy individuals. The results will provide information for designing further studies to examine the safety and effectiveness of this technique in treating… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Electrical Stimulation of the Brain
- What is being tested?
- TMS and EEG
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Oct 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants will be right-handed healthy volunteers aged 18-80 with greater than or equal to 12 years of education.
- Subjects must perform within one standard deviation of the mean on screening with the verbal fluency test.
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.
- History of significant psychiatric illness, i.e. requiring medication or hospitalization.
- Current use of neuroactive medication or recreational drugs.
- History of attention deficit-hyperactivity disorder (ADHD), learning disorder, or any other cognitive deficit.
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- Pregnancy.
- Presence of metal in the head other than dental hardware.
- Broken skin in the area of the stimulating electrodes.
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: A Phase I Trial of Focal DC Brain Polarization
This study will examine the effects of direct current (DC) electrical polarization of the brain on thinking speed, reaction time, mood, and brain waves in healthy individuals. The results will provide information for designing further studies to examine the safety and effectiveness of this technique in treating certain brain diseases involving impaired cognition (thought processing). The study consists of three experiments; participants will take part in either one or two of the experiments.
Healthy right-handed volunteers between 18 and 80 years of age with 12 or more years of education may be eligible for this study. Candidates will be screened with a medical and educational history and a brief neurological examination. Participants in experiments 2 and 3 will also be screened with a verbal fluency test in which they will be asked to say as many words beginning with certain letters as they can in 1 minute.
Read more
Participants will undergo the following procedures for the experiment(s) in which they participate:
Experiment 1
While resting quietly, subjects receive 20 minutes of weak electrical current stimulation or sham stimulation with no current. For the stimulation, two gauze pads soaked with a conducting salt solution are placed on the head-one on the left side and one above the right eye. The current is passed between the pads and may cause an itching or tingling sensation under the electrodes. Before and after the stimulation, the participant's reaction time-tested by moving a finger as fast as possible at the sound of a tone-and mood are evaluated. Some participants also have an electroencephalogram, or EEG (brain wave recording) during the experiment. After the stimulation, participants take two brief tests of thinking speed, and the mood and reaction time tests are repeated.
Experiment 2
The participant sits in a chair with electrodes attached to the muscles that control movement in a finger on the right hand. Reaction time is tested as described in experiment 1. Then, transcranial magnetic stimulation (TMS) is used to test the activity of the brain's motor cortex (the part of the brain that controls movement). For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex. The stimulation may cause twitching of the right hand or arm or produce a mild snapping sensation on the scalp. During the stimulation, the electrical activity of muscles in the right hand is recorded on a computer. Following the TMS, DC stimulation is applied, as described in experiment 1. The stimulation begins at a low level and is followed by repeat TMS and DC stimulation at increasingly higher levels. This continues until there is a clear effect on the muscle response to the magnetic pulses, or until the stimulation becomes uncomfortable. At the end of the electrical stimulation, reaction time is tested again.
Experiment 3
This experiment uses the average DC level that produced a change in the size of the responses to magnetic stimulation in experiment 2. Thinking speed and reaction time are tested during the DC stimulation, and the mood test is given before and during the stimulation. This test does not use TMS or EEG recording.
Read the detailed description
The passage of weak DC currents across the head (DC polarization) has been done for centuries with various effects reported. Many of the reports and studies of DC effects in humans are, however, archaic, anecdotal, uncontrolled, or scientifically baseless. Recently, it has been shown by objective means, in controlled experiments, that this type of treatment has robust and lasting effects on the excitability of the motor cortex in healthy humans. In vitro and animal experiments have revealed little about the mechanism of this effect, but neither has convincing evidence of toxicity been found at moderate doses. Therefore, we are becoming interested in whether this type of treatment can be used to improve cognitive processing in individuals with brain lesions, particularly of the prefrontal cortex. The purpose of this project is to prepare the way for clinical trials by beginning to establish the safety of this technique in humans and then to look for preliminary evidence of potentially useful effects on cognition when moderate doses are applied to the prefrontal cortex. First, we propose to test the safety of 20 min of anodal and cathodal DC applied the left prefrontal area, at 1 mV, by looking for clinical-level effects on verbal fluency, cognitive processing speed, EEG, mood, or motor reaction speed after exposure. The duration of exposure in this study will match the time required to gather preliminary efficacy data in healthy controls and patients. Then, in a dose-finding study, we propose to find the anodal DC amperage necessary for producing a clear effect on excitability, as measured by an increase in the amplitude of the motor evoked potential to transcranial magnetic stimulation. Then, if no significant adverse effects are in the first two studies, a preliminary efficacy study will look for differences in these measures between groups receiving anodal, cathodal, and sham DC of the left prefrontal cortex during stimulation.
- Conditions
- Electrical Stimulation of the Brain
- Being tested
- TMS, EEG
- Keywords
- Frontal Lobe, Motor Cortex, Dementia, Cognition, Healthy Volunteer, HV
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSProcedure or surgery
EEGProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2002 (estimated)
- Study startNov 2002
- Study completionOct 2005
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 Electrical Stimulation of the BrainStudies 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
- 170 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048698
- Sponsor's protocol ID
- 030017
- Other IDs
- 03-N-0017
- Status last verified
- Oct 2005
- First submitted
- 5 Nov 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. doi: 10.1097/00006123-198701000-00030.
PubMed 3808255Baudewig J, Nitsche MA, Paulus W, Frahm J. Regional modulation of BOLD MRI responses to human sensorimotor activation by transcranial direct current stimulation. Magn Reson Med. 2001 Feb;45(2):196-201. doi: 10.1002/1522-2594(200102)45:23.0.co;2-1.
PubMed 11180425Burke D, Hicks R, Gandevia SC, Stephen J, Woodforth I, Crawford M. Direct comparison of corticospinal volleys in human subjects to transcranial magnetic and electrical stimulation. J Physiol. 1993 Oct;470:383-93. doi: 10.1113/jphysiol.1993.sp019864.
PubMed 8068071
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
- A Phase I Trial of Focal DC Brain Polarization
- ClinicalTrials.gov ID
- NCT00048698
- Acronym / sponsor ID
- 030017
- Conditions
- Electrical Stimulation of the Brain
- Keywords
- Frontal Lobe, Motor Cortex, Dementia, Cognition, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Nov 2002
- Study completion
- Oct 2005
- First posted
- 6 Nov 2002 (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 examine the effects of direct current (DC) electrical polarization of the brain on thinking speed, reaction time, mood, and brain waves in healthy individuals. The results will provide information for designing further studies to examine the safety and effectiveness of this technique in treating certain brain diseases involving impaired cognition (thought processing). The study consists of three experiments; participants will take part in either one or two of the experiments.
Healthy right-handed volunteers between 18 and 80 years of age with 12 or more years of education may be eligible for this study. Candidates will be screened with a medical and educational history and a brief neurological examination. Participants in experiments 2 and 3 will also be screened with a verbal fluency test in which they will be asked to say as many words beginning with certain letters as they can in 1 minute.
Participants will undergo the following procedures for the experiment(s) in which they participate:
Experiment 1
While resting quietly, subjects receive 20 minutes of weak electrical current stimulation or sham stimulation with no current. For the stimulation, two gauze pads soaked with a conducting salt solution are placed on the head-one on the left side and one above the right eye. The current is passed between the pads and may cause an itching or tingling sensation under the electrodes. Before and after the stimulation, the participant's reaction time-tested by moving a finger as fast as possible at the sound of a tone-and mood are evaluated. Some participants also have an electroencephalogram, or EEG (brain wave recording) during the experiment. After the stimulation, participants take two brief tests of thinking speed, and the mood and reaction time tests are repeated.
Experiment 2
The participant sits in a chair with electrodes attached to the muscles that control movement in a finger on the right hand. Reaction time is tested as described in experiment 1. Then, transcranial magnetic stimulation (TMS) is used to test the activity of the brain's motor cortex (the part of the brain that controls movement). For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex. The stimulation may cause twitching of the right hand or arm or produce a mild snapping sensation on the scalp. During the stimulation, the electrical activity of muscles in the right hand is recorded on a computer. Following the TMS, DC stimulation is applied, as described in experiment 1. The stimulation begins at a low level and is followed by repeat TMS and DC stimulation at increasingly higher levels. This continues until there is a clear effect on the muscle response to the magnetic pulses, or until the stimulation becomes uncomfortable. At the end of the electrical stimulation, reaction time is tested again.
Experiment 3
This experiment uses the average DC level that produced a change in the size of the responses to magnetic stimulation in experiment 2. Thinking speed and reaction time are tested during the DC stimulation, and the mood test is given before and during the stimulation. This test does not use TMS or EEG recording.
Detailed description
The passage of weak DC currents across the head (DC polarization) has been done for centuries with various effects reported. Many of the reports and studies of DC effects in humans are, however, archaic, anecdotal, uncontrolled, or scientifically baseless. Recently, it has been shown by objective means, in controlled experiments, that this type of treatment has robust and lasting effects on the excitability of the motor cortex in healthy humans. In vitro and animal experiments have revealed little about the mechanism of this effect, but neither has convincing evidence of toxicity been found at moderate doses. Therefore, we are becoming interested in whether this type of treatment can be used to improve cognitive processing in individuals with brain lesions, particularly of the prefrontal cortex. The purpose of this project is to prepare the way for clinical trials by beginning to establish the safety of this technique in humans and then to look for preliminary evidence of potentially useful effects on cognition when moderate doses are applied to the prefrontal cortex. First, we propose to test the safety of 20 min of anodal and cathodal DC applied the left prefrontal area, at 1 mV, by looking for clinical-level effects on verbal fluency, cognitive processing speed, EEG, mood, or motor reaction speed after exposure. The duration of exposure in this study will match the time required to gather preliminary efficacy data in healthy controls and patients. Then, in a dose-finding study, we propose to find the anodal DC amperage necessary for producing a clear effect on excitability, as measured by an increase in the amplitude of the motor evoked potential to transcranial magnetic stimulation. Then, if no significant adverse effects are in the first two studies, a preliminary efficacy study will look for differences in these measures between groups receiving anodal, cathodal, and sham DC of the left prefrontal cortex during stimulation.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be right-handed healthy volunteers aged 18-80 with greater than or equal to 12 years of education.
- Subjects must perform within one standard deviation of the mean on screening with the verbal fluency test.
Key exclusion criteria (9 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.
- History of significant psychiatric illness, i.e. requiring medication or hospitalization.
- Current use of neuroactive medication or recreational drugs.
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 |
|---|---|---|
| TMS | Procedure or surgery | – |
| EEG | Procedure or surgery | – |
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 3808255Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. doi: 10.1097/00006123-198701000-00030.
- Background: PubMed 11180425Baudewig J, Nitsche MA, Paulus W, Frahm J. Regional modulation of BOLD MRI responses to human sensorimotor activation by transcranial direct current stimulation. Magn Reson Med. 2001 Feb;45(2):196-201. doi: 10.1002/1522-2594(200102)45:23.0.co;2-1.
- Background: PubMed 8068071Burke D, Hicks R, Gandevia SC, Stephen J, Woodforth I, Crawford M. Direct comparison of corticospinal volleys in human subjects to transcranial magnetic and electrical stimulation. J Physiol. 1993 Oct;470:383-93. doi: 10.1113/jphysiol.1993.sp019864.
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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 TMS and EEG in people with Electrical Stimulation of the Brain, 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 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 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00048698, 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.