Psychobiological Responses Following Exercise and Brain Stimulation
ConditionPsychological
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorVirginia Commonwealth University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults
aged 18 to 50
consent and complete a Physical Activity Readiness Questionnaire (PAR-Q)
be free from any neurological or psychiatric disorder
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS)
Other interventionSubject 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 interventionSubject 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 interventionNo 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 Inventory
Other interventionA 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 Anxiety
Other interventionThe 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".
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: High density transcranial direct current stimulation (HD-tDCS)Experimental treatment 5 interventions
Trial outcomes
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
Time frame
Completion of 4 visits to research laboratory up to 15 daysSecondary outcomes
1
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
Time frame
Completion of 4 visits to research laboratory up to 15 days2
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.
Time frame
Completion of 4 visits to research laboratory up to 15 daysSponsors and contacts
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Source ClinicalTrials.gov