Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Depression, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/7/2018 |
| Start Date: | June 2014 |
| End Date: | August 2019 |
Randomized Trial of 1 Hz Versus 10 Hz Right Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Posttraumatic Stress Disorder (PTSD)
Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1
Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater
improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS
score. The secondary objectives include: one, testing which treatment provides a
significantly greater improvement in depressive symptoms as measured by change in QIDS score;
two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD
symptoms; and three, testing which treatment is better tolerated as measured by participant
drop out and side effect profiles.
Research Design: Randomized single-blind (raters) prospective clinical trial testing the
effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.
Methodology: Veterans 18 to 50 years of age suffering from PTSD with and without depressive
symptoms will be recruited from the community as well as from the mental health clinics at
the James A. Haley Veterans Administration Hospital. Plan to enroll 50 in order to have an
evaluable sample of approximately 20 in each group. Participants will be consented and
undergo screening for safety and appropriateness to be in the trial. Those deemed eligible
will be evaluated with clinical measures of function, PTSD, depression, pain, and
neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by
significant depression defined as MADRS greater than 19) to one of two active treatments:
right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo
assessment for safety prior to each treatment. The treatments will be performed 5 days a week
for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per
week. Clinical evaluations will be performed at baseline, after every five treatments, at the
end of the treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used
to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal
rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a
significant difference in change in depressive symptoms for both the participants with
significant depressive symptoms and the entire group. The number of dropouts (related
specifically to side effects and all cause) will be used along with side effect profiles to
test for differences in tolerability of the two treatments.
Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater
improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS
score. The secondary objectives include: one, testing which treatment provides a
significantly greater improvement in depressive symptoms as measured by change in QIDS score;
two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD
symptoms; and three, testing which treatment is better tolerated as measured by participant
drop out and side effect profiles.
Research Design: Randomized single-blind (raters) prospective clinical trial testing the
effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.
Methodology: Veterans 18 to 50 years of age suffering from PTSD with and without depressive
symptoms will be recruited from the community as well as from the mental health clinics at
the James A. Haley Veterans Administration Hospital. Plan to enroll 50 in order to have an
evaluable sample of approximately 20 in each group. Participants will be consented and
undergo screening for safety and appropriateness to be in the trial. Those deemed eligible
will be evaluated with clinical measures of function, PTSD, depression, pain, and
neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by
significant depression defined as MADRS greater than 19) to one of two active treatments:
right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo
assessment for safety prior to each treatment. The treatments will be performed 5 days a week
for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per
week. Clinical evaluations will be performed at baseline, after every five treatments, at the
end of the treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used
to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal
rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a
significant difference in change in depressive symptoms for both the participants with
significant depressive symptoms and the entire group. The number of dropouts (related
specifically to side effects and all cause) will be used along with side effect profiles to
test for differences in tolerability of the two treatments.
Inclusion Criteria:
- Male and female veteran outpatients aged 18-50 years old
- Meet DSM-IV criteria for PTSD as determined by clinical interview and CAPS for DSM-5
- A PTSD checklist - (PCL) ≥ 45 at Screening/Baseline
- On stable medication and/or psychotherapy for 1 month and clinically appropriate to
maintain for duration of trial
- Clinically competent to give informed written consent
Exclusion Criteria:
- Veterans currently enrolled in an acute treatment of PTSD using evidence based
psychotherapy including Prolonged Exposure Therapy (PE), Cognitive Processing Therapy
(CPT), or Eye Movement Desensitization and Reprocessing (EMDR)
- History of epilepsy or seizure disorder, mass brain lesions, cerebrovascular accident,
metal in the skull, a history of major head trauma defined as greater than mild TBI,
or any neurologic condition likely to increase risk of rTMS.
- Suicidal risk that precludes safe participation defined as clinical impression that
the subject is at significant risk for suicide.
- Lifetime history of schizophrenia, schizoaffective, or other psychotic disorder,
bipolar disorder type I or II, dementia, dissociative disorders, or sexual and gender
identity disorder
- Personality disorder that makes participation in the trial difficult
- History of problematic Substance Use Disorder in the last 3 months except nicotine and
caffeine
- Taking any medication that significantly lowers the seizure threshold (e.g.,
stimulants, theophylline, first generation antipsychotics, etc.)
- Unstable medical conditions that precludes safe participation in rTMS treatment trial
- Known or suspected pregnancy
- Nursing mothers
- Women of child-bearing potential not using medically accepted form of contraception
when engaged in sexual intercourse
- Any metal or device implants that would increase risk of rTMS
- Unable to determine the motor threshold in the subject
- History of Vagus Nerve Stimulation or Electroconvulsive Therapy
- Currently in another investigational study
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