Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: Transcranial Direct Current Stimulation (tDCS) with Binaural Beats: A transcranial direct current stimulation device, intended to be used for treating Generalized anxiety disorder (GAD)
Sponsors
CLINIERA RESEARCH SOLUTIONS LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults, 18 to 60 years of age at the time of screening of either gender (male and female). 2. Hamilton Anxiety Rating Scale (HAM-A) score = 15 (Final threshold to be determined based on study focus on moderate to severe cases) 3. Subjects must meet all the following criteria for GAD as defined by DSM-5-TR: Excessive anxiety and worry occurring for more days, but not more than 6 months. Difficulty controlling worry = 3 of the following symptoms: Restlessness or feeling keyed up or on edge Being easily fatigued Difficulty concentrating or mind going blank Irritability Muscle tension Sleep disturbance Symptoms cause clinically significant distress or impairment. Diagnosis confirmed by licensed mental health professional 4. No change in the dosage of Psychiatric medication for = 4 weeks prior to enrolment 5. No change in the Psychotherapy = 4 weeks prior to enrolment. 6. There should be no change in Psychiatric medication of the subject during the complete trial period. 7. No planned medication changes during the study period 8. Subjects with ability to sign informed consent form 9. Demonstrated understanding of study nature, risks and benefits 10. Fluent in consent language 11. Willing to comply with all study procedures and follow-up
Exclusion criteria
Exclusion criteria: 1. Subject who participated in other study within the past 3 months. 2. Patients with a history of head trauma. Moderate to severe traumatic brain injury (TBI). Head injury requiring hospitalization. Loss of consciousness for more than 30 minutes in past 3 months. Post-concussive syndrome within past 2 years. 3. Patients with presence of metal implants in or around the head such as Cochlear implants, aneurysm clips, brain stimulators, skull plates, deep brain stimulators, shrapnel or bullet fragments, external hearing aids, any other implants in the opinion of PI hat could interfere with tDCS. 4. Patients with any history of neurological surgery such as brain surgery, neurological procedures involving skull, intracranial or cervical spine surgery, deep brain stimulation procedures. 5. Medical conditions including, cardiovascular disease (heart attacks, artery/valve related issues, arrhythmia etc.), thyroid dysfunction, active autoimmune conditions (systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disorder etc.), chronic pain requiring opioid medication. 6. Patients with history of seizure or epilepsy, on current anticonvulsant medication use. 7. Patients with suicidal tendency such as, suicide attempt, current suicidal ideation, C-SSRS and MADRS score indicating any risk, history of multiple suicide attempts. 8. Dementia or mild cognitive impairment (MMSE score less than 24) 9. Uncorrected hearing/visual impairment affecting participation as per PI opinion. 10. Comorbid conditions which are schizophrenia or psychotic disorder, bipolar disorder (Type I or II), current major depressive episode, interfering personality disorders, psychiatric hospitalization within 6 months, somatoform or dissociate disorders, eating disorders, narcolepsy. 11. Substance use disorder within past 12 months, active substance use (excluding nicotine, caffeine), and alcohol consumption more than 14 units/week within the past week. 12. Subjects undergoing chemotherapy, or with a history of chemotherapy or cancer. 13. Pregnant, breastfeeding/lactating, or planning pregnancy during the study period. 14. If a patient is already enrolled in a clinical trial 15. History of Electroconvulsive Therapy (ECT) 16. Any medical condition apart from those mentioned above which in the opinion of PI would affect the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishing the Safety profile of Transcranial Direct Current Stimulation in Generalized Anxiety Disorder. Reduction in anxiety symptoms, as measured by the provided scales (HAM-A, HDRS, PSQI, K-10, C-SSRS, MADRS and VAS) in the individuals with mild and moderate GAD following the use of the tDCS device.Timepoint: Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in executive function, measured using validated neuropsychological assessments (Trail Making Part B, Mackworth Clock Test, Sternberg Task, Stop Signal Paradigm), in individuals with mild & moderate GAD after the intervention with the tDCS device.Timepoint: Baseline, 1 week, 2 weeks, 3 weeks, & 4 weeks | — |
Countries
India
Contacts
Public ContactKaushik M Gawali
Raja Rajeswari Medical College and Hospital
Outcome results
None listed