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Completed

NCT Number: NCT01659736

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

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).

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06105, United States

About this study

Participants will complete structural MRI for neuronavigation. Participants will be randomly assigned to treatment condition. TMS or Sham-TMS sessions will occur daily 5 days/week for 6 weeks. Assessments will occur at pretreatment, weekly during treatment, post-treatment, and 3 month.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMS

Device

Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.

Other names: Transcranial Magnetic Stimulation

Primary outcomes

  1. Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.

    Time frame: Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up

    Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.

  2. Responder Status

    Time frame: Post-treatment, 6 weeks

    Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.

  3. Remission Status

    Time frame: post-treatment, 6 weeks

    Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at post-treatment.

  4. Responder Status

    Time frame: 3-month follow-up

    Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.

  5. Remission Status

    Time frame: 3-month follow-up

    Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at 3-month follow-up.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Neuronetics

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2012
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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