Trial · NCT03325959
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual analogue Scale (VAS) | at 3 months | The primary end point of the study will be the measurement of daily pain on a (0-10) Visual analogue Scale |
| Primary | Visual analogue Scale (VAS) | at 6 months | The primary end point of the study will be the measurement of daily pain on a (0-10 scale) Visual analogue Scale |
| Secondary | Global Pain Scale (GPS) | baseline, at 3 months, at 6 months | Fibromyalgia syndrome symptoms questionnaire named Global Pain Scale (GPS) questionnaire (0-100 scale) |
| Secondary | Patient global impression of change | baseline, at 3 months, at 6 months | Fibromyalgia syndrome symptoms questionnaire named: Patient global impression of change (yes/no) |
| Secondary | Fibromyalgia Impact Questionnaire | baseline, at 3 months, at 6 months | Fibromyalgia syndrome symptoms questionnaire named: Fibromyalgia Impact Questionnaire - FIQ (Hebrew version) (0-100 scale) |
| Secondary | Wide Spread Pain Index | baseline, at 3 months, at 6 months | Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (WPI) Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (scale 0-19) |
| Secondary | Symptom Severity Scale | baseline, at 3 months, at 6 months | Fibromyalgia syndrome symptoms questionnaire named:Symptom Severity Scale (SSS) (scale 0-12) |
| Secondary | SF-36 questionnaire | baseline, at 3 months, at 6 months | Quality of life questionnaire named short-form 36 (SF-36) (scale 0-100) |
| Secondary | Medical Outcome Sleep Scale | baseline, at 3 months, at 6 months | Sleep qualtiy questionnaire named: Medical Outcome Sleep Scale (MOS) questionnaire (0-100 scale) |
| Secondary | Beck Depression Inventory | baseline, at 3 months, at 6 months | Depression questionnaire named Beck Depression Inventory (BDI-II) (scale 0-63) |
| Secondary | EQ-5D | baseline, at 3 months, at 6 months | Quality of life questionnaire named EQ-5D (scale 0-25) |
| Secondary | Cognitive function | baseline, at 3 months, at 6 months | The Mindstreams battery includes several cognitive tests devised to check various aspects of brain capabilities. In the current study we will evaluate the cognitive indices based on the scores of the 6 cognitive tests listed below, which are expected to be relevant for mild TBI. For detailed description of all cognitive tests in Mindstreams battery |
| Secondary | Cognitive function - CANTAB | baseline, at 3 months, at 6 months | Patients' cognitive functions will be assessed by CANTAB computerized cognitive tests (Cambrdige cognition , England) \[52\]. The CANTAB is a semiautomated test battery which can be administered on a laptop PC and more recently has been modified for administration on a handheld tablet. The current release of CANTAB Eclipse comprises 25 tests designed to assess components of cognitive function which fall into 7 broad groups of tests: visual memory, executive function, working memory and planning, attention, semantic/verbal memory, decision making and response control, social cognition, and screening/familiarization. |
| Secondary | Cerebral blood volume | baseline, at 3 months, at 6 months | Cerebral blood volume (in mililiter) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC). • DSC: 50 T2\*-weighted gradient-echo echo planar imaging (EPI) volumes will be acquired, 2 repetitions before a bolus injection of Gadolinium-DTPA (Gd-DTPA), 48 repetitions after injection of Gd-DTPA. |
| Secondary | Cerebral blood flow | baseline, at 3 months, at 6 months | Cerebral blood volume (in mililiter/min) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC). • DSC: 50 T2\*-weighted gradient-echo echo planar imaging (EPI) volumes will be acquired, 2 repetitions before a bolus injection of Gadolinium-DTPA (Gd-DTPA), 48 repetitions after injection of Gd-DTPA. |
| Secondary | Fractional anistropy | baseline, at 3 months, at 6 months | Brain microstructure imaging will evalute fractional anistropy (FA , scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI). MRI sequence parameters: • DTI: 30 diffusion weighted images will be scanned with different gradient directions (b=1000) and one volume without diffusion weighting |
| Secondary | Mean diffusivity | baseline, at 3 months, at 6 months | Brain microstructure imaging will evalute mean diffusivity (MD, scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI). MRI sequence parameters: • DTI: 30 diffusion weighted images will be scanned with different gradient directions (b=1000) and one volume without diffusion weighting |
| Secondary | Brain function imaging | baseline, at 3 months, at 6 months | Resting state fMRI(rsfMRI or R-fMRI)- a method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task. This resting brain activity is observed through changes in blood flow in the brain which creates what is referred to as a blood-oxygen-level dependent (BOLD) signal that can be measured using functional Magnetic Resonance Imaging (fMRI). |
| Secondary | brain function imaging | baseline, at 3 months, at 6 months | Brain photon emission computed tomography (PET-CT) will be conducted using FDG. |
| Secondary | Brain network analysis | baseline, at 3 months, at 6 months | EEG activity will be recorded at resting state , during performing cognitive tasks and following a trans-magnetic stimulation. EEG recording will be performed using a 64 electrodes cap. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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