HealthyNCT03537885
EEG Analytics to Determine Effectiveness of a tDCS Protocol
A study testing Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation and Electroencephalography (EEG) in people with Healthy and EEG, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
The goal of this study is to monitor the brain using electroencephalography (EEG) while transcranial direct current stimulation (tDCS) is being administered, as a potential pathway to determine neurophysiological markers capable of forecasting the intensity of a subject's response to tDCS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, EEG, Transcranial Magnetic Stimulation
- What is being tested?
- Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation and Electroencephalography (EEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 31 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neurologically healthy
Who cannot join
- Ongoing use of CNS-active medications
- Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
- Presence of a potential tDCS/TMS Risk Factor:
- Damaged skin at the site of stimulation (i.e. skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip or any other electrically sensitive support system
- Metal in any part of the body, including metal injury to the eye (Jewelry must be removed during stimulation)
- A history of medication-resistant epilepsy in the family
- Past history of seizures or unexplained spells of loss of consciousness
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Medical Research Institute
White Plains, New York, 10605
About this study
Official title: Development of an EEG Analytics Tool to Determine Effectiveness of a tDCS Protocol
The goal of this study is to monitor the brain using electroencephalography (EEG) while transcranial direct current stimulation (tDCS) is being administered, as a potential pathway to determine neurophysiological markers capable of forecasting the intensity of a subject's response to tDCS.
Read the detailed description
Transcranial direct current stimulation is a non-invasive neuromodulation technique that has been the subject of many recent investigations. There is a growing body of evidence to suggest that tDCS can enhance the efficacy of various therapies. However, progress in the field is slow: many studies suffer from reproducibility issues, or highly variable results, including stroke rehabilitation. It is feasible that much of the variance in experimental results can be explained by an inability to quantitatively track individual responses to tDCS in real-time, and personalize stimulation parameters for maximum effect.
Monitoring the brain via EEG while tDCS is being administered is a potential pathway to determine neurophysiological markers capable of forecasting the intensity of a subject's response to tDCS. This research has not previously been attempted due to technical difficulties- namely, the electromagnetic interference that is associated with tDCS degrades EEG signal quality. Recent advances in electrode and amplification technology have made it possible to make EEG recordings simultaneously with tDCS.
The investigators will attempt to determine whether specific EEG signatures can indicate the magnitude of a tDCS response. Subjects will receive either real or sham anodal tDCS to the hand representation of their left primary motor cortex.
The efficacy of the tDCS protocol will be quantitatively determined using transcranial magnetic stimulation (TMS) to generate a motor-evoked potential (MEP) in the hand pre- and post-tDCS. Additionally, prior to, during, and following the tDCS protocol, we will record EEG event-related potentials (ERPs) in response to a finger-tapping (motor) task.
The investigators aim to draw a correlation between the magnitude of MEP changes and pre- and post-tDCS and changes in recorded ERPs before, during and after tDCS in order to quantify the response to tDCS over the motor cortex. If EEG metrics can be used to gauge efficacy in real-time during tDCS administration, the investigators will gain significant insight into how to appropriately and quantitatively individualize tDCS dosage parameters for each patient.
- Conditions
- Healthy, EEG, Transcranial Magnetic Stimulation
- Being tested
- Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation, Electroencephalography (EEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDiagnostic test
Electrodes are placed on that head to deliver a non-invasive brain stimulation to the target area.
Transcranial Magnetic StimulationDiagnostic test
A coil is held tangential to the head in order to deliver a non-invasive brain stimulation to the target area.
Electroencephalography (EEG)Diagnostic test
A cap is placed on the head with sensors to detect brain activity during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| TMS, EEG, and tDCS Group | Experimental | Participants will wear a cap fitted with Electroencephalography (EEG) electrodes to detect the brain's activity during the task. Transcranial Magnetic Stimulation will be used to evaluate the brain's responsiveness to Transcranial Direct Current Stimulation.
All study participants will receive the same study procedures - TMS, tDCS, and EEG. Receives: Diagnostic Test: Transcranial Direct Current Stimulation; Diagnostic Test: Transcranial Magnetic Stimulation; Diagnostic Test: Electroencephalography (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Evoked Potential
A measure of the muscle's responsiveness to non-invasive stimulation.
Measured: Within session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Feb 2015
- Primary completion27 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537885
- Sponsor's protocol ID
- BRC493
- Status last verified
- Aug 2024
- First submitted
- 15 May 2018
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an EEG Analytics Tool to Determine Effectiveness of a tDCS Protocol
- ClinicalTrials.gov ID
- NCT03537885
- Acronym / sponsor ID
- BRC493
- Conditions
- Healthy, EEG, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 May 2018 (actual)
- 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 goal of this study is to monitor the brain using electroencephalography (EEG) while transcranial direct current stimulation (tDCS) is being administered, as a potential pathway to determine neurophysiological markers capable of forecasting the intensity of a subject's response to tDCS.
Detailed description
Transcranial direct current stimulation is a non-invasive neuromodulation technique that has been the subject of many recent investigations. There is a growing body of evidence to suggest that tDCS can enhance the efficacy of various therapies. However, progress in the field is slow: many studies suffer from reproducibility issues, or highly variable results, including stroke rehabilitation. It is feasible that much of the variance in experimental results can be explained by an inability to quantitatively track individual responses to tDCS in real-time, and personalize stimulation parameters for maximum effect.
Monitoring the brain via EEG while tDCS is being administered is a potential pathway to determine neurophysiological markers capable of forecasting the intensity of a subject's response to tDCS. This research has not previously been attempted due to technical difficulties- namely, the electromagnetic interference that is associated with tDCS degrades EEG signal quality. Recent advances in electrode and amplification technology have made it possible to make EEG recordings simultaneously with tDCS.
The investigators will attempt to determine whether specific EEG signatures can indicate the magnitude of a tDCS response. Subjects will receive either real or sham anodal tDCS to the hand representation of their left primary motor cortex.
The efficacy of the tDCS protocol will be quantitatively determined using transcranial magnetic stimulation (TMS) to generate a motor-evoked potential (MEP) in the hand pre- and post-tDCS. Additionally, prior to, during, and following the tDCS protocol, we will record EEG event-related potentials (ERPs) in response to a finger-tapping (motor) task.
The investigators aim to draw a correlation between the magnitude of MEP changes and pre- and post-tDCS and changes in recorded ERPs before, during and after tDCS in order to quantify the response to tDCS over the motor cortex. If EEG metrics can be used to gauge efficacy in real-time during tDCS administration, the investigators will gain significant insight into how to appropriately and quantitatively individualize tDCS dosage parameters for each patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS, EEG, and tDCS Group | Experimental | Diagnostic Test: Transcranial Direct Current Stimulation, Diagnostic Test: Transcranial Magnetic Stimulation, Diagnostic Test: Electroencephalography (EEG)Participants will wear a cap fitted with Electroencephalography (EEG) electrodes to detect the brain's activity during the task. Transcranial Magnetic Stimulation will be used to evaluate the brain's responsiveness to Transcranial Direct Current Stimulation. All study participants will receive the same study procedures - TMS, tDCS, and EEG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neurologically healthy
Key exclusion criteria (8 listed)
- Ongoing use of CNS-active medications
- Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
- Presence of a potential tDCS/TMS Risk Factor:
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 StimulationElectrodes are placed on that head to deliver a non-invasive brain stimulation to the target area. | Diagnostic test | TMS, EEG, and tDCS Group |
| Transcranial Magnetic StimulationA coil is held tangential to the head in order to deliver a non-invasive brain stimulation to the target area. | Diagnostic test | TMS, EEG, and tDCS Group |
| Electroencephalography (EEG)A cap is placed on the head with sensors to detect brain activity during the intervention. | Diagnostic test | TMS, EEG, and tDCS Group |
Primary outcome
Motor Evoked Potential
Time frame: Within session
A measure of the muscle's responsiveness to non-invasive stimulation.
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 6 Aug 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers at this time.
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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 study testing Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation and Electroencephalography (EEG) in people with Healthy and EEG, run by Burke Medical Research Institute 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 6 Aug 2024. 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?
Motor Evoked Potential (time frame: Within session). 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 6 Aug 2024.