Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT06874595

Conditions

Psychological

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS)

Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS)

No exercise followed by HD-tDCS (no exercise + HD-tDCS).

State Anxiety Inventory

Visual Analog Scale for Anxiety

Study Details

Brief summary:

Anxiety disorders are the most common mental health diagnosis in the US; 19.1% of U.S. adults (23.4% for females and 14.3% for males). In addition, the Global Burden of Disease study (2010) found that anxiety disorders were the sixth leading cause of disability (years of life lived with disability). These debilitating disorders are characterized by excessive worry and fear about everyday situations, and physical symptoms including restlessness, being easily fatigued, difficulty concentrating, irritability, muscle tension, or sleep disturbance. Furthermore, anxiety is linked to other mental disorders including depression and substance abuse; is associated with cardiovascular disease risk factors and a higher rate of cardiovascular disease; and is related to premature mortality. These data have led to the investigation of a breadth of plausible treatments for anxiety, including medications and psychotherapy. However, likely due to the breadth of complex mechanisms involved in the pathophysiology of anxiety disorders and the unfavorable side effects of various medications, a considerable number of individuals do not have a satisfactory response to these treatments. This has led investigators to examine plausible novel interventions to alleviate anxiety and its symptoms.

Conditions

Psychological

Study ID

NCT06874595

Start date

Mar 19, 2025

Status verified date

Mar, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy adults
  • aged 18 to 50
  • consent and complete a Physical Activity Readiness Questionnaire (PAR-Q)
  • be free from any neurological or psychiatric disorder
  • not be taking any medication that could affect the central nervous system
  • not have any contraindication for HD-tDCS (i.e. not having metal implanted in the head, pacemaker, medical bumps, seizures, lesions on the scalp or head ) or for bioelectrical impedance (i.e., electronic medical implant, such as a pacemaker or implantable cardioverter defibrillator, and limb amputation)
  • not be regular users of tobacco products (cigarettes, cigars, chewing tobacco)
  • not consume an average of more than ten alcoholic beverages per week

Exclusion Criteria:

  • Individuals who do not meet the PAR-Q screening criteria for participation in moderate physical activity will be excluded from participating in this study
  • women who are pregnant will be exclude from this study

Study Design

Enrollment

29 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High density transcranial direct current stimulation (HD-tDCS)

HD-tDCS (High-definition transcranial direct current stimulation) is a novel non-invasive brain stimulation (NIBS) technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation.

Interventions

Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS)

Subject will complete a Cycling exercise at 65% of HRR for 20 minutes and then a High-definition transcranial direct current stimulation (HD-tDCS) is a non-invasive brain stimulation technique that uses small electrodes to deliver weak electric currents to the scale. Transcranial direct current stimulation (tDCS) uses weak direct currents of the order of 0.5 mA to 4 mA to modulate cortical activity by exciting or suppressing underlying neurons.

Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS)

Subject will complete a Cycling exercise at 65% of HRR for 20 minutes and then a sham High-definition transcranial direct current stimulation (HD-tDCS) is a non-invasive brain stimulation technique that uses small electrodes to deliver weak electric currents to the scale. Transcranial direct current stimulation (tDCS) uses weak direct currents of the order of 0.5 mA to 4 mA to modulate cortical activity by exciting or suppressing underlying neurons.

No exercise followed by HD-tDCS (no exercise + HD-tDCS).

No exercise but a High-definition transcranial direct current stimulation (HD-tDCS) is a non-invasive brain stimulation technique that uses small electrodes to deliver weak electric currents to the scale. Transcranial direct current stimulation (tDCS) uses weak direct currents of the order of 0.5 mA to 4 mA to modulate cortical activity by exciting or suppressing underlying neurons.

State Anxiety Inventory

A widely used psychological assessment tool designed to measure both state and trait anxiety. 40 self-report items rated on a 4-point Likert scale (1 = "Almost Never" to 4 = "Almost Always"). Higher scores indicate higher levels of anxiety. Scores are compared to normative data to determine if they fall within the range of typical or clinical anxiety.

Visual Analog Scale for Anxiety

The Visual Analogue Scale for Anxiety (VASA) is a 100-millimeter line that helps people measure how anxious they feel. The scale has a mark on the left end that indicates "not at all anxious" and a mark on the right end that indicates "very anxious".

Primary outcome measure

  • Examine the anxiolytic effects of high density transcranial direct current stimulation (HD-tDCS) "primed" with physical activity (PA) [ Time Frame: Completion of 4 visits to research laboratory up to 15 days ]

Central Contacts and Locations

Central contacts

Edmund Acevedo

(804) 814-4355eoacevedo@vcu.edu

Monique Morton

804-828-1948mortonmy@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Edmund Acevedo, PhD

804-828-1948eoacevedo@vcu.edu

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Exercise and Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-03-16.