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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

9mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

Study Progress61%

Mar 2025Feb 2027

First Submitted

Initial submission to the registry

February 4, 2025

Completed

1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed

6 days until next milestone

Study Start

First participant enrolled

March 19, 2025

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

February 4, 2025

Last Update Submit

March 12, 2026

Conditions

Psychological

Keywords

Exercise and Brain Stimulation

Outcome Measures

Primary Outcomes (1)

Examine the anxiolytic effects of high density transcranial direct current stimulation (HD-tDCS) "primed" with physical activity (PA)
Physical activity prior to HD-tDCS will enhance the anxiolytic effects beyond the benefits of physical activity alone and HD-tDCS alone. Thus, demonstrating a priming effect of PA on the anxiety alleviating electrical pathways that HD-tDCS activates at subthreshold level. Visual Analog Scale for Anxiety (VAS-Anxiety; rating from 0 = "not at all anxious" to 100 = "the most anxious I have ever felt") and three other scales assessing tingling, stiffness and numbness will be administered with a similar VAS
Completion of 4 visits to research laboratory up to 15 days

Secondary Outcomes (2)

Cerebral hemodynamics assessment
Completion of 4 visits to research laboratory up to 15 days
HRV parameters will be acquired and calculated
Completion of 4 visits to research laboratory up to 15 days

Study Arms (1)

High density transcranial direct current stimulation (HD-tDCS)

EXPERIMENTAL

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.

Other: Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS)Other: Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS)Other: No exercise followed by HD-tDCS (no exercise + HD-tDCS).Other: State Anxiety InventoryOther: Visual Analog Scale for Anxiety

Interventions

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

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.