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NCT03672747

Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I

Completed NA Results posted Last updated 31 July 2024
What this trial tests

NA trial testing transcranial direct-current stimulation (tDCS) in Brain Function in 133 participants. Completed in 31 May 2023.

Timeline
20 February 2019
Primary endpoint
14 October 2022
31 May 2023

Quick facts

Lead sponsorUniversity of Nebraska
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment133
Start date20 February 2019
Primary completion14 October 2022
Estimated completion31 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska

Who can join

Adults 19 to 72, any sex, with Brain Function. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Behavioral Performance (Accuracy) on Cognitive Tests of Perceptual Processing Primary · During the 90 minutes following stimulation

Do participants perform better in terms of accuracy following tDCS on behavioral measures of perceptual processing.

GroupValue95% CI
Anodal Stimulation97± 1.26
Cathodal Stimulation98± 1.05
Sham Stimulation (Placebo)98± .94
The Power of Spontaneous Alpha Activity as Quantified by MEG Imaging Secondary · During the 90 minutes following stimulation

Does spontaneous alpha (9-13 Hz) power, as measured by MEG, get stronger following tDCS. Spontaneous activity refers to the level of background neural activity and is typically divided into frequency bands (e.g., alpha, gamma) that reflect the number of cycles per second. The outcome measure unit is nano-amperes square (nA\^2) since source-resolved MEG measures reflect electric current strength and not voltage units as in electroencephalography (EEG). The square is necessary since we examined power, which is the square of amplitude in the frequency domain. The unit is also commonly expressed a

GroupValue95% CI
Anodal Stimulation23.26± 3.06
Cathodal Stimulation15.88± 2.18
Sham Stimulation (Placebo)17.02± 2.46
The Power of Oscillatory Alpha Activity as Quantified by MEG Imaging Secondary · During the 90 minutes following stimulation

Does oscillatory alpha neural activity, as measured by MEG, get stronger following tDCS. Oscillatory activity refers band-limited increases or decreases in the power of neural activity, relative to baseline, in response to a stimulus.

GroupValue95% CI
Anodal Stimulation-27.34± 3.18
Cathodal Stimulation-26.10± 3.03
Sham Stimulation (Placebo)-30.88± 5.11
Behavioral Performance (Reaction Time) on Cognitive Tests of Perceptual Processing Primary · During the 90 minutes following stimulation

Do participants perform better in terms of reaction time following tDCS on behavioral measures of perceptual processing.

GroupValue95% CI
Anodal Stimulation713± 67
Cathodal Stimulation708± 58
Sham Stimulation (Placebo)724± 52
The Power of Spontaneous Gamma Activity as Quantified by MEG Imaging Secondary · During the 90 minutes following stimulation

Does spontaneous gamma (45-80 Hz) power, as measured by MEG, get stronger following tDCS. Spontaneous activity refers to the level of background neural activity and is typically divided into frequency bands (e.g., alpha, gamma) that reflect the number of cycles per second. The outcome measure unit is nano-amperes square (nA\^2) since source-resolved MEG measures reflect electric current strength and not voltage units as in electroencephalography (EEG). The square is necessary since we examined power, which is the square of amplitude in the frequency domain. The unit is also commonly expressed

GroupValue95% CI
Anodal Stimulation3.46± 1.74
Cathodal Stimulation3.30± 1.89
Sham Stimulation (Placebo)2.43± 1.55
The Power of Oscillatory Gamma Activity as Quantified by MEG Imaging Secondary · During the 90 minutes following stimulation

Does oscillatory gamma neural activity, as measured by MEG, get stronger following tDCS. Oscillatory activity refers band-limited increases or decreases in the power of neural activity, relative to baseline, in response to a stimulus.

GroupValue95% CI
Anodal Stimulation10.78± 2.74
Cathodal Stimulation6.35± 1.98
Sham Stimulation (Placebo)6.28± 1.87

Sponsor's own description

This study will determine whether transcranial direct current stimulation (tDCS) can be used alter the amplitude of spontaneous neural activity, and thereby modulate cognitive function in healthy adults

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Brain Function

Currently open trials in the same condition.

Other University of Nebraska trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03672747.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing