NCT06874595

Psychobiological Responses Following Exercise and Brain Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Transcranial direct current stimulation (tDCS), a non-invasive central neuromodulatory technique that is inexpensive and safe, has been utilized to stimulate specific regions of the brain and has demonstrated promising results for alleviating anxiety and depression. (1) evidence supports the administration of anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) to excite neuronal activity and cathodal stimulation over the right DLPFC to inhibit activity (a bicephalic tDCS montage with 2 mA of stimulation at the left DLPFC) as the most effective tDCS treatment to alleviate anxiety in humans and (2) that "tDCS may be more effective when used in combination with drugs and cognitive behavioral therapies". However, results from studies that have examined the neurophysiological and behavioral effects of tDCS are not consistent. This is likely because the highest cortical current density may not have occurred directly under the target electrode, thus altering the effects of tDCS. High-density tDCS (HD-tDCS) is similar to conventional tDCS utilizing anode and cathode placement on the scalp to produce unidirectional current flow, however, to enhance precision and accuracy, HD-tDCS utilizes smaller electrodes and most often in a "4X1 ring" montage (center anode electrode surrounded by four return cathode electrodes). This HD-tDCS montage delivers a precise current to the intended target site and has been found to be well tolerated and safe for healthy humans. Furthermore, the utilization of HD-tDCS can facilitate the elucidation of mechanisms of action that can provide greater clarity regarding discrepant results in the literature and for considering future advancements in enhancing effective HD-tDCS implementation strategies. HD-tDCS stimulation increases the membrane potential by several millivolts without triggering an action potential.

Conditions

• Psychological

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	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.
OTHER	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.
OTHER	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".

Timeline

• Start date: 2025-03-19
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-03-13
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study