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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

4 Study Matches

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History (PATH)

This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Hannah.Cabrera@UTSouthwestern.edu

Christian LoBue
All
55 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05446584
STU-2022-0591
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Inclusion Criteria:

• Active diagnosis of amnestic mild cognitive impairment
• Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample
• Female and male subjects
• All races/ethnicities
• Age 55 years and older
• Fluent in English
Exclusion Criteria:

• Mild traumatic brain injury within past year
• Lifetime history of moderate or severe brain injury
• Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor)
• Lifetime major cardiovascular conditions (e.g., heart attack, heart failure)
• Current substance use disorder
• Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder)
• Current vision or hearing impairment that interferes with testing
• Any electronic and or metallic implants in the skull or brain
• Current medication use known to alter HD-tDCS reactivity
Device: High Definition Transcranial Direct Current Stimulation
Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder, Amnestic Mild Cognitive Impairment, Mild Traumatic Brain Injury, Concussion, Brain, Brain and Nervous System
MCI, TBI, memory, biomarker, Alzheimer
UT Southwestern; Parkland Health & Hospital System
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Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (PATTERN)

The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Victoria.Castillo@UTSouthwestern.edu

Fatma Gul
ALL
18 Years to 85 Years old
PHASE3
This study is NOT accepting healthy volunteers
NCT03992404
STU-2019-0894
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Inclusion Criteria:
* Female or male subject ≥ 18 years and ≤ 85 years at screening * Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury * Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus * Modified Ashworth Scale-Bohannon \[MAS\] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended) * Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion * At least 4 months since last botulinum neurotoxin \[BoNT\] injection for treatment of spasticity or any other condition * For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an: * Activated partial thromboplastin time \[aPTT\] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or * International normalized ratio \[INR\] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
Exclusion Criteria:
* Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study * Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity * Body weight \< 50 kg * Severe atrophy of the target limb muscles * Previous, ongoing or planned treatments of spasticity with intrathecal baclofen * Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: Surgical Intervention; Alcohol or phenol block; Muscle afferent block * Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study * Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening * Infection or inflammation at the injection sites * Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment * Pregnancy (as verified by a positive pregnancy test) or breast feeding
DRUG: NT 201, DRUG: Placebo
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury, Other, Brain and Nervous System
UT Southwestern; Parkland Health & Hospital System
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Safeguarding the Brain of Our Smallest Infants Phase III (SafeBoosC)

the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants during the first 72 hours of life will result in a reduction in severe brain injury or death at 36 weeks postmenstrual age.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Pollieanna.Sepulveda@UTSouthwestern.edu

Lina Chalak
All
up to 6 Hours old
N/A
This study is NOT accepting healthy volunteers
NCT03770741
STU-2019-1707
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Inclusion Criteria:

• Infants born with postmenstrual age less than 28 weeks
• Signed informed consent, unless the NICU has chosen to use 'opt-out' or deferred consent as consent method.
Exclusion Criteria:

• Missing written parental informed consent (if the 'opt-out' method is used for consent, lack of a record that the clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record in the infant's clinical file of parents' decision to opt-out, are exclusion criteria)
• Decision not to conduct full life support
• No possibility to place cerebral NIRS oximeter within six hours after birth
Other: Modify cardio-respiratory support to avoid cerebral hypoxia, Other: Treatment as usual
Infant, Extremely Premature, Brain Injuries, Death, Brain, Death, Neonatal
Near-infrared spectroscopy, NIRS, Cerebral oximetry, Extremely preterm, Brain injury, Mortality, Treatment guideline
Children’s Health; Parkland Health & Hospital System
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Brain Networks and Consciousness

General anesthesia (GA) is a medically induced state of unresponsiveness and unconsciousness, which millions of people experience every year. Despite its ubiquity, a clear and consistent picture of the brain circuits mediating consciousness and responsiveness has not emerged. Studies to date are limited by lack of direct recordings in human brain during medically induced anesthesia. Our overall hypothesis is that the current model of consciousness, originally proposed to model disorders and recovery of consciousness after brain injury, can be generalized to understand mechanisms of consciousness more broadly. This will be studied through three specific aims. The first is to evaluate the difference in anesthesia sensitivity in patients with and without underlying basal ganglia pathology. Second is to correlate changes in brain circuitry with induction and emergence from anesthesia. The third aim is to evaluate the effects of targeted deep brain stimulation on anesthesia induced loss and recovery of consciousness. This study focuses on experimentally studying these related brain circuits by taking advantage of pathological differences in movement disorder patient populations undergoing deep brain stimulation (DBS) surgery. DBS is a neurosurgical procedure that is used as treatment for movement disorders, such as Parkinson's disease and essential tremor, and provides a mechanism to acquire brain activity recordings in subcortical structures. This study will provide important insight by using human data to shed light on the generalizability of the current model of consciousness. The subject's surgery for DBS will be prolonged by up to 40 minutes in order to record the participant's brain activity and their responses to verbal and auditory stimuli.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Sahil.Chilukuri@UTSouthwestern.edu

Nader Pouratian
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04502550
STU-2021-0396
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Inclusion Criteria:

• Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
• Clinical diagnosis of Parkinson's disease or essential tremor
• Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
Exclusion Criteria:

• Patients with recent use (within one week) of anticoagulant or antiplatelet agent use
• Neurocognitive testing indicating amnestic cognitive deficits
• History of intolerance of propofol or medical indications to use an anesthetic other than propofol
Drug: Propofol
Loss of Consciousness, Parkinson Disease, Essential Tremor, Anesthesia, Brain and Nervous System
general anesthesia, deep brain stimulation, basal ganglia, thalamus, sensorimotor cortex
UT Southwestern
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See this study on ClinicalTrials.gov