Exercise and Brain Stimulation for Anxiety

Overseen By Monique Morton

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: CNS medications

Disqualifiers: Neurological, Psychiatric, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to reduce anxiety through exercise and brain stimulation. Participants will cycle and receive HD-tDCS, a brain stimulation technique using mild electric currents to target specific areas. The trial seeks healthy adults without neurological or psychiatric disorders who do not use tobacco or drink excessively. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could lead to new anxiety treatments.

Will I have to stop taking my current medications?

Yes, you must not be taking any medication that could affect the central nervous system to participate in this trial.

What prior data suggests that these treatments are safe for anxiety?

Research has shown that high-definition transcranial direct current stimulation (HD-tDCS) is generally safe. In earlier studies, most participants experienced either no sensation or only mild sensations during sessions, and no serious safety issues were reported.

HD-tDCS stimulates the brain non-invasively, using gentle electrical currents on specific scalp areas to affect brain activity. This method has shown promise in treating conditions like anxiety and depression, with few side effects.

These findings suggest that HD-tDCS is well-tolerated and could be a promising option for those exploring new treatments for anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of high-density transcranial direct current stimulation (HD-tDCS) for treating anxiety because it offers a novel approach compared to traditional treatments like medication and talk therapy. Unlike standard options that primarily focus on chemical imbalances or behavioral strategies, HD-tDCS uses targeted electrical currents to non-invasively stimulate specific areas of the brain. This technique could lead to faster and potentially more precise relief from anxiety symptoms without the side effects commonly associated with medications. By directly modulating brain activity, HD-tDCS opens up new possibilities for treating anxiety in a way that current methods do not.

What evidence suggests that this trial's treatments could be effective for anxiety?

Research has shown that high-definition transcranial direct current stimulation (HD-tDCS), a treatment under study in this trial, might help reduce anxiety symptoms. This non-invasive method uses gentle electric currents to stimulate specific brain areas. Some studies suggest that HD-tDCS can lessen anxiety and depression, particularly when targeting the left dorsolateral prefrontal cortex, a region involved in mood control. However, results have varied, with some studies finding no significant difference compared to a placebo treatment. Overall, while HD-tDCS appears promising, further research is needed to confirm its effectiveness for anxiety. ^{3 6 7 8 9}

Who Is on the Research Team?

Edmund Acevedo

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cycling exercise
• HD-tDCS

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36307858/

High-definition transcranial direct current stimulation (HD ... This randomized control trial aims at assessing the efficacy of HD-tDCS on ameliorating the depressive, cognitive and anxiety symptoms, and improving the daily ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X24000713

Results from a randomized, double-blind, controlled trial With a response rate of 26.1% in the active stimulation group and 23.8% in the sham stimulation group, there was no significant difference in efficacy observed.

3. nature.com nature.com/articles/s41398-024-03003-w

Evaluating the effects of tDCS on depressive and anxiety ... tDCS over the left DLPFC is effective in reducing depressive symptoms and shows promising effects in alleviating anxiety symptoms among individuals with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05322863

High-definition Transcranial Direct Current Stimulation (HD ... This study is a double-blinded randomized sham-controlled trial to test the effectiveness of HD-tDCS as augmentation therapy for antidepressants in patients ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838763

Personalized High-Definition Transcranial Direct Current ... In this randomized clinical trial, mood in participants with moderate to severe depression significantly improved after 12 days of left DLPFC ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218548/

Tolerability and blinding of high-definition transcranial ... There were no safety-related adverse events. HD-tDCS was well tolerated with mostly no (“none”) or “mild” sensations reported across sessions, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07099521

The Effects of High-definition Transcranial Direct Current ... To examine the offline effects of high-definition tDCS (HD-tDCS) on attention, interpretation and memory biases in youth with social anxiety. Official Title.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02481765

Feasibility and Dose Tolerability of HD-tDCS in Healthy ... tDCS has been shown to improve motor learning, visuomotor coordination, probabilistic classification, boost memory in humans and was found to be well tolerated ...

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08157-y

High-definition transcranial direct current stimulation (HD ... The results revealed that the HD-tDCS has significant efficacy in the treatment among MDD patients with anxious distress. The rate of adverse ...