Exercise and Brain Stimulation for Anxiety

Overseen By Monique Morton

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Virginia Commonwealth University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Edmund Acevedo

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for healthy adults aged 18 to 50 who can exercise and have no neurological or psychiatric disorders. They shouldn't be on CNS-affecting meds, use tobacco regularly, drink heavily, or be pregnant. They must pass a physical activity readiness questionnaire.

Inclusion Criteria

Not be regular users of tobacco products

I am between 18 and 50 years old and healthy.

Consent and complete a Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion Criteria

Individuals who do not meet the PAR-Q screening criteria for participation in moderate physical activity

I am currently pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high density transcranial direct current stimulation (HD-tDCS) combined with physical activity to examine anxiolytic effects

2 weeks

4 visits to research laboratory

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cycling exercise (Behavioural Intervention)
• HD-tDCS (Behavioural Intervention)

Trial Overview The study tests how brain stimulation (HD-tDCS) after cycling exercise affects anxiety levels compared to just HD-tDCS without exercise or sham tDCS after exercising. Participants' anxiety responses are measured using standardized scales.

Participant Groups

Group I: High density transcranial direct current stimulation (HD-tDCS) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+