Official Title A Multi-center, Phase 1/2a, First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults with Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered via Magnetic Resonance Imaging (MRI)-guided Convection-enhanced Delivery (CED)

Purpose

You are being invited to participate in a study about mesial temporal lobe epilepsy (MTLE) on only 1 side (unilateral) of the brain that has not responded to medication (refractory).

The study will test AMT-260, which is a new gene therapy under investigation for use in treating people like you with MTLE. It is not yet approved as a drug for treating MTLE. It can only be used in a study like this one. This is the first time this gene therapy will be used in humans. It has previously been studied in animals.

AMT-260 is a gene therapy designed to reduce the electrical signals between nerve cells (neurons) in the parts of your brain where nerve cells are abnormally connected. This reduces the extra electrical signals that happen at the same time and is intended to reduce your seizure activity.

The overall goals of this study are:

• To observe whether participants have any side effects from AMT-260 or from the procedure to deliver AMT-260 into the brain and how well participants tolerate any side effects that may occur.
• To measure if participants have changes in:
  • frequency of their seizures
  • how their seizures affect their life
  • how the human body takes up and removes AMT-260
• To find the best dose of AMT-260 for future participants to ensure clinical benefit with minimal or no side effects.

Could this study be right for you?

Adult, 18-65 years of age, inclusive, capable of giving informed consent.
Written informed consent is given freely after the nature of the study has been explained to the participant and the completion of data disclosure.
Willingness to undergo necessary surgical procedures.
Diagnosis of unilateral refractory MTLE for ≥360 days, confirmed by an Epilepsy Monitoring Unit.

Additional Eligibility Criteria to be assessed by neurosurgery team, and as described in the study protocol.

Age Range

18 - 65 years

Official Title A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Escalating Doses of LH-001 in Healthy Subjects

Purpose

The purpose of this study is to evaluate the safety and tolerability of an investigational new drug in healthy participants aged 18-60 years.

Could this study be right for you?

• In good health and BMI (ratio of body weight to height) between 18-26 kg/m2
• Willing to participate in various research assessments including blood collection, urine collection, electrocardiogram, and vital signs
• Willing to stay overnight (~30 hours) in the OSU Hospital Clinical Research Center
• If sexually active, willing to utilize highly effective birth control during the study period
• Not currently pregnant or breast-feeding
• No significant medical condition involving any major organs (heart, lung, liver, brain, or endocrine)
• No any of the following: cancer, alcohol or substance abuse, spleen problems, or drug hypersensitivity
• No history of or undergoing treatment for: major psychiatric illness, seizures, or autoimmune disease
• Not currently taking immunosuppressive drugs
• No active Hepatitis B, Hepatitis C, or HIV

Age Range

18 - 60 years

Official Title Patterns Of Survivors’ Recovery Trajectories in the ICECAP trial 􀂥POST-ICECAP􀂦

Purpose

The purpose of this study is to describe the physical, neuropsychological outcomes of adults who have experienced an outside of hospital cardiac arrest; and examine any associations between those outcomes and any clinical and/or rehabilitative interventions and/or social determinants of health.

Could this study be right for you?

• Experienced a coma after resuscitation from a cardiac arrest
• Received targeted/controlled body temperature management
• Survived to at least 1 month after experiencing a outside of hospital cardiac arrest

Age Range

18 years and up

Official Title A Single-Stage, Adaptive, Open-Label Dose Escalation Safety Study of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase (AAV2-hAADC) Administered by MR- guided Infusion into the Midbrain in Pediatric Patients with AADC Deficiency

Purpose

The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in children with aromatic L-amino acid decarboxylase (AADC) deficiency, and to see if there is a demonstration of effective restoration of AADC function by assays of CSF neurotransmitter metabolites and F-DOPA PET imaging, as allowed by subject’s ability to travel to undergo follow-up visits.

Could this study be right for you?

Inclusion Criteria

• Diagnosis of AADC deficiency from genetic test and CSF/blood enzyme test
• Failed to derive adequate benefit from standard medical therapy as judged by presence of residual oculugyric crises and developmental delay.
• Documented history of motor developmental delay, with inability to walk independently without support by age 18 months.
• Both parents (or legal guardians) must give their consent for their child’s participation in the study unless (i.) one parent is deceased, unknown or incompetent; (ii.) one parent is not reasonably available; or (iii.) one parent has responsibility for the care and custody of the child.

Inclusion Criteria varies, please contact Study Coordinator for more information.

Exclusion Criteria

• Presence of other significant medical or neurological conditions that would create an unacceptable operative or anesthetic risk.
• Previous stereotactic neurosurgery.
• Coagulopathy, or need for ongoing anticoagulant therapy.
• Receipt of any investigational agent within 60 days prior to Baseline and during study participation.

Exclusion Criteria varies, please contact Study Coordinator for more information.

Age Range

2 years and up

Official Title CareNet: An Interactive Digital Tool to Assess Informal Caregiving Networks of Older Adults with Dementia

Purpose

We are interested in understanding the dynamics of caregiving when multiple caregivers are involved in caring for an older adult with memory problems. We would like to interview the primary caregiver in a brief one-time interview about their thoughts and experiences in providing care for an older adult with memory problems. 

Could this study be right for you?

Participants must be:

• An unpaid caregiver of an older adult with memory loss problems
  • The older adult must be 65 years or older
  • The older adult must not live in a residential care/assisted living facility
• Able to identify at least one other unpaid caregiver for the older adult with memory loss problems
• Able to communicate in English

Age Range

18 years and up

Official Title Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Purpose

The purpose of this study is to determine whether spinal cord stimulation (SCS) will reduce pain in patients with painful Diabetic Peripheral Neuropathy (DPN).

Could this study be right for you?

Inclusion Criteria:

• Over 18 years old
• Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic
• Diagnosis of medically refractory pain secondary to diabetic neuropathy
• Presence of pain for 12 months

Exclusion Criteria:

• Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
• Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
• Coagulopathy that cannot be corrected
• Unable to discontinue blood thinning medications

Inclusion and Exclusion Criteria varies, please contact Study Coordinator.

Age Range

18 years and up

Official Title An open-label clinical trial evaluating the ExAblate Model 4000 Type-1 focused ultrasound unilateral thalamotomy for patients with treatment-refractory focal onset epilepsy and comorbid anxiety

Purpose

The purpose of the study is to learn more about whether an ultrasound treatment for epilepsy and anxiety is safe and effective.

Could this study be right for you?

• Age: 18-65 years old
• Treatment resistant Epilepsy (focal or partial-onset seizures)
• ≥ 3 seizures/month
• Moderate-to-severe Anxiety

 

 

Age Range

18 - 65 years

Official Title MapLight Study (IRIS Clinical Trial)

Purpose

The purpose of this study is to investigate a medication intended to improve social communication in adolescents and adults with ASD.

Could this study be right for you?

• Have an autism diagnosis or suspect you have an autism diagnosis
• Have a caregiver or study partner willing to enroll in the study with you

Age Range

18 - 45 years

Official Title Understanding the Neurodevelopmental Effects of Youth Tackle Football Participation

Purpose

In this study we are aiming to identify risk factors for higher exposure to football-related neurotrauma in youth tackle football players and to determine the effects of football-related neurotrauma exposure on neurodevelopment in children with no previous tackle football participation.

For this specific posting, we are looking for boys ages 8-12 who are non-athletes or athletes who play non-contact sports to serve as control subjects for our fMRI study. 

Could this study be right for you?

We are looking for boys ages 8-12 who are either non-athletes or do not participate in any contact sports.

• Boys must have no metal implanted in the body
• Have no prior history of head trauma
• Have no serious health or mental health diagnoses
• Must not have a fear of enclosed spaces

Age Range

8 - 12 years

Official Title Exploring the Connectivity and Functional Organization of the Infant Brain

Purpose

The purpose of the study is to investigate how the brain that we are each born with leads to our own unique behavior later in life, and the similarities and differences between maternal and child brains. We are studying infants prenatally and postnatally, following up with them as they grow and develop, and studying their mothers to understand how similar/different they are to their child.

Could this study be right for you?

• Infants under 3 years of age, and pregnant persons who are at least 20 weeks pregnant
• All participants must have no metal implanted in the body
• Have no significant health conditions or history of serious mental illness
• Not suffer from a (fear of enclosed spaces)
• Pregnancies must be without complication.

Age Range

Up to 40 years