Cranial Electrotherapy Stimulation (CES) to Treat PTSD



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 40
Updated:4/2/2016
Start Date:May 2010
End Date:May 2015

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Cranial Electrotherapy Stimulation (CES) to Treat PTSD: Identifying Metrics of Efficacy Using Brain Imaging

Use of the Fischer Wallace Cranial Stimulator to relieve symptoms related to PTSD.

The advent of an appreciation that alternative and complementary practices can have some
beneficial effect on health has prompted the question of whether there are empirical
measures of improvement that do not rely solely on subjective reports. The present study
proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation;
CES) using an FDA-approved device can alter brain function, mood and responses to cognitive
tasks in patients diagnosed with Post Traumatic Stress Disorder (PTSD). Furthermore, the
study will test whether such changes parallel clinical improvement in signs and symptoms.
The dependent variables of interest will be magnetic resonance imaging (MRI). Secondarily,
we will assess the effects of CES on brain chemistry through the use of magnetic resonance
spectroscopy procedures in normal, healthy control participants.

Inclusion Criteria:

- Meets DSM-IV criteria for PTSD

- 21 to 40 years old

- Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries)

- Female participants must use medically approved method of contraception. If barrier
method is used, they must agree to using two methods simultaneously (e.g., diaphragm
and condom).

- If on antidepressant or antianxiety medication, must be on a stable prescription
regimen with no intentions to change drugs or dose during the next 11 weeks.

Exclusion Criteria:

- Opiate maintenance (e.g., methadone or buprenorphine)

- Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses.

- Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or
marihuana). Past abuse/dependence (greater than 3 years) is acceptable.

- Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years)
is acceptable. They may meet criteria for alcohol abuse.

- Physical health problems

- History of significant cardiac problems

- History of seizures

- Pregnancy

- Persons with a demand-type cardiac pacemaker

- Persons receiving vagus nerve simulation

- Persons receiving deep brain stimulation

- Participants cannot have any conditions that are contraindicated for MRI
We found this trial at
1
site
115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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Belmont, MA
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