Thermal Clinic Treatment in Gulf War Illness
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Posttraumatic Stress Disorder
In brief
Although thermal therapy has been utilized in the rehabilitation of war veterans since the Roman Empire, no investigations actually exist about the use of thermal therapy in GWI, This due to the fact that nobody knows that the cure for the syndrome in GWI veterans may exist in thermal therapy which is the primary objective of this investigation.
Key facts
- Study ID
- NCT02293291
- Run by
- American Society Of Thermalism And Climatology Inc
- People needed
- 100
- Starts
- 2014-09-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2015-06-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) will be used for diagnosis
- Patients aged 18 and <65 at the time of signing the Informed consent
- Male and female patients
- Inpatient/outpatient status: Both are permitted
- Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own)
- Patients whose combined score of the CAPS-SX standard B, C, and D is over 50
You may not qualify if…
- Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia [simple phobia], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase)
- Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD
- Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant
- Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase)
- Patients with a history or complication of manic psychosis
- Patients with a history or complication of convulsive disorder (epilepsy, etc.)
- Patients with a diagnosis or complication of a cognitive disorder (MMSE <=24 points)
- Patients with a history and complication of serious cerebral organic disorder. (e.g. cerebrovascular disorder, meningitis, degenerative disease and other neurological disorders and seizures; however, bleeding in the upper arachnoid membrane should not be excluded)
- Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia)
- Patients with glaucoma
- Patients with a known tendency for bleeding or those with predisposing conditions
- Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or hematopoietic dysfunction, etc.). For seriousness, Grade 3 of "Criteria for seriousness of adverse reactions to drugs, etc. (Yakuan No.80)" is used as an index
- Patients with a history or complication of cancer or malignant tumour
- Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody
- Others whom the investigator or sub-investigator considers ineligible for or unable to participate in the investigation
Where it is running
- Gaviota Clinic — Newark, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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