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N/A N=133 Randomized Double-blind Basic Science

Modulation of Spontaneous Cortical Activity by tDCS: BRAIN Initiative I

Brain Function

Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Behavioral Performance (Accuracy) on Cognitive Tests of Perceptual Processing — 97; 98; 98 percent correct

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
transcranial direct-current stimulation (tDCS) (Device)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
University of Nebraska
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Behavioral Performance (Accuracy) on Cognitive Tests of Perceptual Processing
97; 98; 98
PRIMARY
Behavioral Performance (Reaction Time) on Cognitive Tests of Perceptual Processing
713; 708; 724
SECONDARY
The Power of Spontaneous Alpha Activity as Quantified by MEG Imaging
23.26; 15.88; 17.02
SECONDARY
The Power of Oscillatory Alpha Activity as Quantified by MEG Imaging
-27.34; -26.10; -30.88
SECONDARY
The Power of Spontaneous Gamma Activity as Quantified by MEG Imaging
3.46; 3.30; 2.43
SECONDARY
The Power of Oscillatory Gamma Activity as Quantified by MEG Imaging
10.78; 6.35; 6.28

Summary

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

Eligibility Criteria

Inclusion Criteria

  • Informed consent obtained from the participant.
  • Age: 19-35 years of age at enrollment or 55-72 years of age at enrollment.
  • Gender: males and females included.
  • Right-handed based on the Edinburgh Handedness Inventory
  • Cognitive functioning: Intelligent Quotient (IQ) of 85 - 115 on the Wechsler Adult Intelligence Scale-Revised
  • Ability to complete the questionnaires in English, as not all the neuropsychological tests and questionnaires have been validated in other languages.

Exclusion Criteria

  • Current use of the following medications: psychotropic medications or other medications with significant CNS effects (e.g., antipsychotics, psychostimulants, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, and sedating antihistamines), or other excluded medication.
  • Current psychiatric diagnosis based on the Mini-International Neuropsychiatric Interview (MINI) and/or the adult attention-deficit/hyperactivity disorder (ADHD) diagnostic interview.
  • Current substance abuse or substance dependence at any time.
  • The presence of a known neurological disorder or any major medical illness or injury impacting neurological/psychiatric function (e.g., diabetes, epilepsy, cerebral palsy, traumatic brain injury, significant environmental/toxic injury, neurodegenerative disorder, past meningitis/encephalitis).
  • General medical conditions: any major medical conditions that would interfere with involvement in the study or may affect central nervous system (CNS) function as judged by the investigative team.
  • History of clinically-significant head trauma.
  • Pregnancy
  • Any other condition that, in the opinion of the investigator, is a contraindication to participation
  • The presence of any ferrous metal implant, including orthodontics (e.g., braces), which may interfere with the MEG data acquisition and/or be a MRI safety concern.
  • Inability to correct visual acuity to 20/20 with corrective lenses (we can correct from +5 to -6 diopters in .5 diopter steps, separately for each eye, with non-magnetic corrective lenses in the laboratory).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03672747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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