PsychologicalNCT06874595
Psychobiological Responses Following Exercise and Brain Stimulation
A study testing Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS), No exercise followed by HD-tDCS (no exercise + HD-tDCS). and State Anxiety Inventory in people with Psychological, run by Virginia Commonwealth University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological
- What is being tested?
- Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS), No exercise followed by HD-tDCS (no exercise + HD-tDCS). and State Anxiety Inventory
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Edmund Acevedo, PhD, 804-828-1948, eoacevedo@vcu.edu
About this study
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.
Read the 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
- Being tested
- 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
- Keywords
- Exercise and Brain Stimulation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS)Other
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).Other
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 InventoryOther
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 AnxietyOther
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".
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Inventory; Other: Visual Analog Scale for Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Completion of 4 visits to research laboratory up to 15 days
Secondary outcomes (2)
Cerebral hemodynamics assessment
Cerebral hemodynamics will be assessed utilizing a Portalite near-infrared spectroscopy (NIRS) device . Changes in cerebral hemodynamics are strongly correlated, both spatially and temporally, with changes in neural activity. The Portalite NIRS system utilizes near-infrared light, which penetrates the skull and brain but is absorbed by hemoglobin (Hb) chromophores in capillary, arteriolar, and venular beds
Measured: Completion of 4 visits to research laboratory up to 15 days
HRV parameters will be acquired and calculated
IHRV parameters will be calculated using the HRV analysis function included in the Biopac AcqKnowledge software. The root mean square of successive differences between normal heartbeats (RMSSD) is obtained by calculating each successive time difference between heartbeats in milliseconds. Then, each of the values is squared and the result is averaged before the square root of the total is obtained. The RMSSD reflects the beat-to-beat variance in HR and is the primary time-domain measure used to estimate the vagally mediated changes reflected in HRV. In addition, low frequency (LF) and high frequency (HF) HRV parameters will be computed in absolute power (ms2). High frequency (HF: 0.15-0.4 Hz) is associated with parasympathetic activity and low frequency (LF: 0.04 - 0.15 Hz) is related to both parasympathetic and sympathetic activity, as it may represent baroreflex-mediated autonomic nervous system (ANS) modulation.
Measured: Completion of 4 visits to research laboratory up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start19 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures design; same subjects, same dependent variables across multiple time points, during three conditions
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmund Acevedo, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874595
- Sponsor's protocol ID
- HM20031307
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychobiological Responses Following Exercise and Brain Stimulation
- ClinicalTrials.gov ID
- NCT06874595
- Acronym / sponsor ID
- HM20031307
- Conditions
- Psychological
- Keywords
- Exercise and Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures design; same subjects, same dependent variables across multiple time points, during three conditions
| Arm | Type | Receives |
|---|---|---|
| High density transcranial direct current stimulation (HD-tDCS) | Experimental | 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 Inventory, Other: Visual Analog Scale for AnxietyHD-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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | High density transcranial direct current stimulation (HD-tDCS) |
| 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 | High density transcranial direct current stimulation (HD-tDCS) |
| 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 | High density transcranial direct current stimulation (HD-tDCS) |
| State Anxiety InventoryA 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 | High density transcranial direct current stimulation (HD-tDCS) |
| Visual Analog Scale for AnxietyThe 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". | Other | High density transcranial direct current stimulation (HD-tDCS) |
Primary outcome
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
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
2 secondary outcomes
Cerebral hemodynamics assessment
Time frame: Completion of 4 visits to research laboratory up to 15 days
HRV parameters will be acquired and calculated
Time frame: Completion of 4 visits to research laboratory up to 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edmund Acevedo principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS), No exercise followed by HD-tDCS (no exercise + HD-tDCS). and State Anxiety Inventory in people with Psychological, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edmund Acevedo ((804) 814-4355, eoacevedo@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.