N/A
N=26
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01659736 ↗Enrolled (actual)
26
Serious AEs
4.0%
Results posted
Jan 2016
Primary outcome: Primary: Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up. — 25.31; 20.75; 12.10; 14.38 units on a scale — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hartford Hospital
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up. |
25.31; 20.75; 12.10; 14.38; 10.36; 17.95 | 0.006 sig |
| PRIMARY Responder Status |
7; 0 | — |
| PRIMARY Remission Status |
6; 0 | — |
| PRIMARY Responder Status |
7; 0 | — |
| PRIMARY Remission Status |
6; 0 | — |
Summary
This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by conducting a pilot randomized-controlled trial (RCT) comparing structural neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety Disorder (GAD).
Eligibility Criteria
Inclusion Criteria
- Diagnosed with GAD as the principal or co-principal disorder
- Clinical Global Impression Score ≥ 4
- Hamilton Anxiety Rating Scale ≥ 18
- Hamilton Rating Scale for Depression ≤ 17
- 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 past 3 months.
- Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within 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
Data sourced from ClinicalTrials.gov (NCT01659736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.