Official Title A Screening Study Assessing Eligibility of Idiopathic Parkinson’s Disease Patients for Potential Future Intraputamenal Transplant Study with a Dopaminergic Precursor Product

Purpose

The purpose of this screening study is to identify eligible patients with Parkinson's Disease for a clinical trial in cell transplantation to a part of the brain called the putamen.  The cell transplantation will be of precursors of dopamine producing neurons (the precursors are intended to turn into mature neurons).  

In the screening study patients will be evaluated for the following:

• To characterize your Parkinson's Disease symptoms using information from clinical assessments, genetic tests, blood tests, and imaging of the brain.
• Determine if you qualify for a future Phase 1b/2a transplant study to the putamen
• To collect imaging information about dopamine function and brain function in Parkinson's Disease using 2 scans called a F-DOPA PET and a FDG PET
• To study your blood and urine for biomarkers

Could this study be right for you?

Inclusion Criteria (summarized)

1. Diagnosis of Idiopathic Parkinson’s Disease 
2. Currently using anti-parkinsonian medications and experience some benefits from the medications.
3. Both sides of your body experience symptoms of Parkinson's Disease
4. Not currently pregnant or planning to get pregnant 
5. Willing and able to avoid deep brain stimulation (DBS) during the course of the study and for at least 18 months after transplantation should the study participant be eligible for the interventional phase
6. Willing and able to avoid treatment with continuous apomorphine IV infusions or Duodopa® during the course of the study

Exclusion Criteria (summarized)

1. Diagnosis of secondary or atypical parkinsonism.
2. Previous infusion therapy or surgery for PD.
3. Severe dyskinesia (mild to moderate levadopa induced dyskinesia is acceptable)
4. Clinically significant hallucinations requiring antipsychotic use in the previous 6 months.
5. Use of dopamine antagonists within 90 days of screening.
6. Currently active major depression that is not well controlled
7. History of any cancer (other than treated basal or squamous cell carcinoma) within past 3 years 
8.  Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days prior to screening.
9. Known PD gene mutation or causative variant as informed by genetic testing.
10. Unable to have a MRI

Age Range

45 - 75 years

Official Title A User-Friendly, Non-Invasive Neuro-Orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors with Tetraplegia

Purpose

This study is testing a new wearable device designed to help people with spinal cord injuries regain movement and control in their hands. The device uses electrical signals from the muscles to assist with hand movements. We are exploring whether using this device can improve hand function, support long-term recovery, and help track progress over time. The results will guide future development and testing to bring this technology into everyday rehabilitation and home use.

This is a 20 week study where you will complete a 12-week rehabilitation training protocol (3x/week, 1-2 hours/session) with our study therapist.  Additionally, you will participate in six sessions where clinical assessments will be conducted to measure your arm/hand function.

 

Could this study be right for you?

• Cervical spinal cord injury sustained at least 1 year ago 
• Unable to grasp and manipulate objects to allow independent performance of activities of daily living
• Able to actively move your shoulder and elbow 
• Not currently active in upper extremity rehabilitation

Age Range

22 years and up

Official Title Visual Search Strategy in Neurodivergent Populations

Purpose

The NeuroLab is looking at differences in how Autistic and Neurotypical adults pay attention to their surrounding environment. Previous studies have found that autistic individuals are often better at focusing on visual cues—things they see in their environment—and this study wants to understand what causes that difference. To do so, participants will come in for 2-3 hours and complete computer games, paper and pencil games, and surveys. The goal is to learn how attention works for different people and why Autistic individuals might focus on visual cues differently.

Could this study be right for you?

• Have a medical diagnosis of Autism
• Have normal or corrected color vision
• Can communicate verbally

Age Range

18 - 40 years

Official Title Lifestyle solutions to postprandial hypotension in spinal cord injury

Purpose

To test if a low-glycemic diet and electrical stimulation of leg muscles can improve blood pressure control after eating.

Could this study be right for you?

• Spinal cord injury sustained at least 1-year ago
• Level of injury between C4 and T10
• Use of wheelchair for majority of daily activities

Age Range

18 years and up

Official Title Neural Biomarkers of Sensory Symptoms in Autism

Purpose

The purpose of this study is to understand sensory processing in children on the autism spectrum, Using EEG, we will look at brainwaves while children play different computer games. We will also have children play some paper-pencil games during their visit to our lab. We hope to better understand sensory experiences and support autistic people in ways that celebrate their unique strengths.

Could this study be right for you?

Inclusion criteria for the autism group are

• Diagnosis of autism from a licensed psychologist based on the Autism Diagnostic Interview-Revised or the Autism Diagnostic Observation Schedule (ADOS),
• Aged 8 - 12 years old
• Normal/corrected vision/hearing, and IQ > 65. 19 Children taking stimulant medications will be included in the study but will be required to be off medication for 24 (for short-acting preparations) to 48 h (long-acting preparations) prior to the visit 

Inclusion criteria for the age-matched TD control group include:

• No concerns/diagnoses of any neurodevelopmental, learning, or mental health conditions 

Age Range

8 - 12 years

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