Neuromodulation for Dysphoria

Dysphoria Clinical Trial

Official title:

Neuromodulation for Dysphoria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061745
• Other study ID #: STUDY00002372
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: August 2026

Study information

• Verified date: January 2024
• Source: Florida State University
• Contact: Isabelle Taylor, MA
• Phone: 850-644-2824
• Email: FSUN[@]med.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label prospective pilot study of two neuromodulation interventions for patients suffering from dysphoria. Dysphoria is a transdiagnostic symptom of unease or dissatisfaction experienced across a range of diagnoses, including mood disorders and pain. There is a significant gap of treatment options across conditions with dysphoria, particularly non-medicated and self-care alternatives.

Many neuromodulation therapies require extensive medical resources or time to deliver. Thus, the investigators will test two non-invasive technologies administered in a manner that would reduce resources and/or time. Virtual Reality (VR) overlays the sensory system to block the external environment and provide vast range of meaningful sensory experiences. Transcranial Magnetic Stimulation (TMS) involves a magnetic pulse passing through the scalp to depolarize neurons in the outer cortex of the brain, and daily treatments over 6 weeks are currently FDA indicated for the treatment of major depressive disorder. Accelerated TMS is the delivery of treatment in a shorter period of time.

The primary objective of this study to demonstrate the preliminary effectiveness, tolerability, and feasibility of these two interventions: Guided Meditation VR for Wellness and Accelerated Transcranial Magnetic Stimulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Arm 1:

1. Adults age 18 years and above

2. Reported symptoms of dysphoria: PHQ-9 = 10; GAD-7 = 10; PCL-5 = 45 or Average Pain Intensity = 4/10 for > 3 months - this will ensure at least moderate level of reported difficulty with mood, anxiety, trauma, or pain

3. No changes in psychotropic medication (if taking psychotropic medication) and/or supportive psychotherapy for 1 month prior to baseline visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.

4. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria for Arm 1:

1. Significant auditory or visual impairment that prevents participants from using Virtual Reality headset.

2. Neurologic conditions or devices impacting brain circuitry (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)

3. Active substance use disorder or hallucinogen use in last 3 months or any current substance use that puts the participant at increased risk or significant impairment

4. Dementia or other cognitive disorder making unable to engage in treatment

5. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.

6. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.

7. OCD cannot be the primary disorder but can have OCD symptoms

8. Inability to stop taking any medication that significantly increases cortical excitability (e.g., tricyclic antidepressants, stimulants, clozapine, etc.)

9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in this phase of the study (e.g., unstable metabolic abnormality, unstable angina, etc.)

10. Severe Traumatic Brain Injury

11. We will exclude non-English speakers because of the need for rapid communication before and during the use of technology.

12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).

13. The following groups will NOT be included.

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Prisoners

Inclusion for Arms 2 and 3:

1. Adults age 18 years and above

2. Reported symptom of dysphoria: PHQ-9 = 10; GAD-7 = 10; PCL-5 = 45 or Average Pain = 4/10 for > 3 months - this will ensure at least moderate level of reported difficulty with mood, anxiety, trauma, or pain

3. No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial

4. Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study

Exclusion for Arms 2 and 3 :

1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)

2. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment

3. Dementia or other cognitive disorder making unable to engage in treatment

4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, delusional Disorder or other psychotic illness that precludes safe participation in trial

5. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide

6. OCD cannot be the primary disorder but can have OCD symptoms

7. Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)

8. Current, planned, or suspected pregnancy

9. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)

10. Severe Traumatic Brain Injury

11. We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments

12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).

13. The following groups will NOT be included.

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Dysphoria

Intervention

Device:
• Guided Meditation VR for Wellness
Selected Modules of Commercially Available "Guided Meditation VR" presented on Valve Index Headset
• Accelerated Transcranial Magnetic Stimulation: Treatment A
Either MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP) or The NeuroStar® System will be used.
• Accelerated Transcranial Magnetic Stimulation: Treatment B
Either MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP) or The NeuroStar® System will be used.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm 1 Hypothesis 1	Primary Outcome will be determined by descriptive feasibility metrics. Feasibility will be determined by number of patients enrolled.	Week 2
Primary	Arm 1 Hypothesis 2	Primary Outcome measure is SF-36 Short Form for all patients.	Week 2
Primary	Arm 1 Hypothesis 3	Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.	Week 2
Primary	Arm 1 Hypothesis 4	Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.	From Baseline over 10 weeks
Primary	Arm 2 Hypothesis 1	Primary Outcome measure is the SF-36 Short Form for all participants.	Week 2
Primary	Arm 2 Hypothesis 2	Primary Outcome measure is the clinician-administered scale that tracks the designated primary disorder.	Week 2
Primary	Arm 2-3 Hypothesis 3	Primary Outcome measure is SF-36 Short Form for all participants.	From Baseline to Week 6
Primary	Arm 2-3 Hypothesis 4	Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.	Week 2
Primary	Arm 2-3 Hypothesis 4-Treatment B	Primary outcome (Treatments A and B). Tolerability will be assessed by side effect profile.	Treatment B-Week 6
Primary	Arm 3 Hypothesis 5	Primary Outcome measure is the SF-36 Short Form for all participants. Significantly greater improvement in rating scores from baseline of Treatment A Exit Visit ("Follow Up A1" or "Follow Up A5") to "Follow Up B1" will be tested (t-test).	Treatment B - Week 2