Non-invasive treatments for dysphoria using neuromodulation techniques

Neuromodulation for Dysphoria

This study is testing two non-invasive treatments, Virtual Reality and Transcranial Magnetic Stimulation, to see if they can help people with feelings of unease or dissatisfaction caused by mood disorders and pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Florida State University (other)
• Locations: 1 site (Tallahassee, Florida)
• Trial ID: NCT05061745 on ClinicalTrials.gov

What this trial studies

This open-label pilot study investigates two non-invasive neuromodulation interventions aimed at alleviating dysphoria, a symptom of unease or dissatisfaction common in various mood disorders and pain conditions. The study will utilize Virtual Reality (VR) to provide immersive sensory experiences and Transcranial Magnetic Stimulation (TMS) to stimulate brain activity. Participants will undergo these treatments over a six-week period, with the goal of offering effective alternatives to traditional medication and therapy. The study seeks to address the significant gap in treatment options for dysphoria, particularly those that are non-medicated.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have reported moderate to severe symptoms of dysphoria for at least three months.

Not a fit: Patients with significant auditory or visual impairments or those with certain neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new, effective non-medicated treatment options for patients suffering from dysphoria.

How similar studies have performed: While neuromodulation techniques have been explored in various contexts, this specific combination of VR and TMS for dysphoria is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Tallahassee, Florida

• Florida State University — Tallahassee, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: F. Andrew Kozel, M.D., M.S.C.R., D.F.A.P.A. — Florida State University
• Study coordinator: Isabelle Taylor, MA

Conditions: Dysphoria, Neuromodulation