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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02479906 |
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Date of registration:
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15/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)
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Scientific title:
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A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) Deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-Traumatic Stress Disorder (PTSD) |
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Date of first enrolment:
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November 17, 2016 |
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Target sample size:
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203 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02479906 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Israel
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United States
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Contacts
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Name:
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Avraham Zangen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ben-Gurion University of the Negev |
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Name:
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Zafiris J. Daskalakis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Addiction and Mental Health (CAMH) |
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Name:
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Moshe Isserles, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Ein Karem Medical Center and Center for Addiction and Mental Health (CAMH) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Outpatients
- Men and women 22-68 years of age
- Subjects currently diagnosed with PTSD according to the DSM-5, using the CAPS-5
(past-month version), with the following criteria met:
- Criterion B: at least 1/5 intrusion symptoms; and
- Criteria C: at least 1/2 avoidance symptoms; and
- Criteria D: at least 2/7 cognition & mood symptoms; and
- Criteria E: at least 2/6 arousal & reactivity symptoms; and
- Criterion F: duration is met; and
- Criteria G: distress is met.
- Subjects with at least moderate PTSD with a CAPS-5 score = 25 at both Screening and
Baseline visits.
- Subjects with an HDRS-21 score = 26 at both Screening and Baseline visits.
- Subjects with negative or mitigated answers on safety screening questionnaire for
transcranial magnetic stimulation.
- Negative pregnancy test in childbearing age women.
- Subject is capable and willing to provide informed consent.
- Subject is able to adhere to the treatment schedule.
Exclusion Criteria:
- Subject diagnosed according to the SCID I as suffering from any other major Axis I
disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not
contraindicated when HDRS-21=26).
- Subjects diagnosed according to the SCID II as suffering from Severe Personality
Disorder.
- Subjects with significant suicidal risk as assessed by the investigator using the Beck
Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the
past year.
- Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by
ECT).
- Subject has a history of significant head trauma with loss of consciousness for longer
than 5 minutes.
- Subject has a history of cranial surgery.
- Subject has metallic particles in the eye or head (exclusive of mouth), implanted
cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators,
intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants,
or electrodes) or implanted medical pumps.
- Subject has severe and frequent headaches.
- Subject has a history of significant hearing loss.
- Subjects with a significant neurological disorder or insult including, but not limited
to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- MMSE = 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Subject with a history of substance abuse including alcoholism within the past 6
months (except nicotine and caffeine).
- Inadequate communication with the patient.
- Subject is under custodial care.
- Subject is currently participating in another clinical study or enrolled in another
clinical study within 30 days prior to this study.
- Subject with unstable physical disease such as unstable cardiac disease.
- Subject is currently on Benzodiazepine at a dose higher than 3 mg of Lorazepam or
equivalent.
- Subject has had previous treatment with TMS.
- Women who are breast-feeding.
- Women of childbearing potential and not using a medically accepted form of
contraception when sexually active.
Age minimum:
22 Years
Age maximum:
68 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Post-Traumatic Stress Disorder
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Intervention(s)
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Device: Deep TMS System
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Device: Sham Treatment
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Primary Outcome(s)
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CAPS-5 Score
[Time Frame: 5 weeks from baseline]
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Secondary Outcome(s)
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Response Rate
[Time Frame: 5 weeks from baseline]
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Secondary ID(s)
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CTP-PTSD-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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