Generalized Anxiety Disorder study: EXOMIND
Official title Device for Treating Generalized Anxiety
ClinicalTrials.gov ID: NCT07819773
What this study is testing
- What it's testing
- The study wants to find out whether an accelerated treatment with the BTL‑699‑2 device reduces anxiety symptoms three months after treatment and to assess its safety.
- Who it's for
- Adults 22 years or older who have been diagnosed with generalized anxiety disorder.
- What's involved
- Participants will receive either real or sham brain stimulation twice a week for about four weeks (16 sessions total), plus questionnaires about anxiety, mood, and well‑being, and occasional urine pregnancy tests for women who could become pregnant.
- Time commitment
- The trial lasts about four months, with screening, eight treatment visits over four weeks, and follow‑up visits at one month and three months after the last treatment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Age ≥ 22 years
- A diagnosis of GAD according to DSM-5 criteria, confirmed by a qualified clinician at screening
- Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required...
- people willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of anxiety...
- Willingness to comply with study instructions and to return to the clinic for the required visits
You likely can't join if
- Metallic objects in or near the head rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other...
- Implanted stimulator devices
- Active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve...
- Drug pumps
- Application in the heart area
- Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)
See the full eligibility criteria
- Age ≥ 22 years
- A diagnosis of GAD according to DSM-5 criteria, confirmed by a qualified clinician at screening
- Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb
- people willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of anxiety, including non-invasive brain stimulation treatments other than the study...
- Willingness to comply with study instructions and to return to the clinic for the required visits
- Women of child-bearing potential\ are required to use birth control measures during the whole duration of the study
- If applicable, people must be maintained on their pre-study psychotherapeutic regimen and any prescribed chronic medications at a stable therapeutic dose for ≥4 weeks prior to enrollment, with no dose or usage frequency...
- Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal.
- Metallic objects in or near the head rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the...
- Implanted stimulator devices
- Active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death.
- Drug pumps
- Application in the heart area
- Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)
- Anticoagulation therapy
- Severe or life-threatening condition
- Pulmonary insufficiency
- Heart disorders
- Renal insufficiency
- Decompensated\ \ hemorrhagic conditions
- Decompensated\ \ blood coagulation disorders
- Decompensated\ \ cardiovascular diseases
- Malignant tumor or benign tumor
- Fever
- Pregnancy
- Active suicidal intent\ \ \
- History of suicide attempts in the last 3 years
- History or concurrent use of electroconvulsive therapy or vagus nerve stimulation
- Substance-induced depression or depression secondary to a general medical condition
- Seasonal affective disorder
- Substance abuse
- Substance dependence 3 months prior
- A psychotic disorder including schizoaffective disorder, bipolar disease, borderline personality disorder or major depression with psychotic features
- Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders
- Ongoing intake disorders such as bulimia or anorexia, or intake disorder in the past fiscal year
- History of increased intracranial pressure or head trauma
- Nursing
- Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study
- Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes.
- By means of decompensation, it means a patient with a proven medical history of a decompensated health condition and long-term medication.
- Defined by a score of Level 4 or Level 5 on the Columbia-Suicide Severity Rating Scale (CSSRS).
The study team makes the final eligibility decision.
Where it is enrolling
- Denver, Colorado, United States
- Chicago, Illinois, United States
- Newburgh, Indiana, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Denver, Colorado, United States; Chicago, Illinois, United States; Newburgh, Indiana, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.