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EEG Analytics to Determine Effectiveness of a tDCS Protocol

Development of an EEG Analytics Tool to Determine Effectiveness of a tDCS Protocol

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03537885
Enrollment
27
Registered
2018-05-25
Start date
2015-02-01
Completion date
2018-12-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EEG, Healthy, Transcranial Magnetic Stimulation

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTTranscranial Direct Current Stimulation

Electrodes are placed on that head to deliver a non-invasive brain stimulation to the target area.

DIAGNOSTIC_TESTTranscranial Magnetic Stimulation

A coil is held tangential to the head in order to deliver a non-invasive brain stimulation to the target area.

DIAGNOSTIC_TESTElectroencephalography (EEG)

A cap is placed on the head with sensors to detect brain activity during the intervention.

Sponsors

Burke Medical Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Neurologically healthy

Exclusion criteria

* 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: 1. 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) 2. Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip or any other electrically sensitive support system 3. Metal in any part of the body, including metal injury to the eye (Jewelry must be removed during stimulation) 4. A history of medication-resistant epilepsy in the family 5. Past history of seizures or unexplained spells of loss of consciousness

Design outcomes

Primary

MeasureTime frameDescription
Motor Evoked PotentialWithin sessionA measure of the muscle's responsiveness to non-invasive stimulation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026