Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Hartford Hospital

Status: Terminated

Conditions: Generalized Anxiety Disorder

Treatments: Device: rTMS Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01815099

DIEF003523.3

Details and patient eligibility

About

We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.

Full description

We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved < 50% improvement in HARS at 3 month follow-up.
• Fluency in English
• Capacity to understand the nature of the study and willingness to sign informed consent form

Exclusion criteria

• History of epilepsy or head trauma (LOC > 5 minutes) within the past 6 months
• Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery
• A review of patient medications by the study physician indicates an increased risk of seizure
• An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
• Substance use disorder or PTSD within the past 6 months
• Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder
• Any psychotic features, including dementia or delirium
• Concurrent psychotherapy and unwillingness to discontinue
• Medication change within the past 4 weeks
• Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months
• Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
• Any contraindication for participation in MRI scan

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

rTMS Treatment

Experimental group

Description:

Clinical participants will receive rTMS

Treatment:

Device: rTMS Treatment