NCT00517400CompletedPhase 1
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder
Hadassah Medical Organization1 site in 1 country30 target enrollmentStarted: February 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- CAPS SCORE [TOTAL, INTRUSION]
Study Overview
Brief Summary
Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD).
Comparing real to sham treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PTSD diagnosis per DSM IV
Exclusion Criteria
- •Schizophrenia
- •Bipolar I
- •severe Axis II diagnosis
- •risk factors to convulsions
- •drug / alcohol abuse
Arms & Interventions
Exposure-Stimulation
Active Comparator
Intervention: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham (Device)
Sham exposure - Real stimulation
Active Comparator
Intervention: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham (Device)
Exposure - Sham Stimulation
Active Comparator
Intervention: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham (Device)
Outcomes
Primary Outcomes
CAPS SCORE [TOTAL, INTRUSION]
Time Frame: 4 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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