Search Results
An Intermediate Expanded Access Protocol with CNM-Au8for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 180 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.
Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 144-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.
Male or female aged 18 years or greater at time of ALS diagnosis
Participants with a confirmed diagnosis of ALS as determined by a neurologist specializing in ALS
Participant is able to consume up to 240mL of investigational drug without substantial dsyhpagia or can take the investigational drug through a gastronomy tube
Participant has a history of clinical significant or unstable medical condition that may interfere with assessment of safety or compromise the study objectives
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
The Ecology of Infant Emotion-Regulation
This study aims to understand how emotion regulation in infants develops within the context of family and community support. We're particularly interested in the relation between mother-infant synchrony, facilitated by family and community support, and infant emotion regulation. We will use a multi-method approach to collect simultaneous brain activation in mothers and infants, infant's physiological responses, and information about family and community support.
Participants complete questionnaires online, then come in for 1 in-person visit. This research aims to find out how patterns of brain activation in infants and mothers and infant physiological responses relate to the real life, face-to-face interactions that mothers and babies usually engage in.
50
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Augmented Reality: Perceptions, Performance, and Language Enhancement
This is a single-center feasibility study assessing the Apple Vision Pro as a device for augmentative and alternative communication in patients with Amyotrophic Lateral Sclerosis who are experiencing impaired communication.Participants in this study will visit the study site once for approximately 1.5 hours. During the session, participants will complete questionnaires about their medical history, undergo an eye exam, and use an augmented reality headset that tracks the motion of the eyes to communicate.
Participants and their caregivers will complete a single visit at the Hershey Medical Center lasting approximately 1.5 hours. During this time, they will undergo an eye exam, answer a set of questionnaires, and use an augmented reality (AR) headset that tracks eye-gaze to communicate.
$25
Use of augmentative and alternative communication device device (including but not limited to: eye tracking, switch control, scanning interface, written or typed communication).
Score of 1 or 0 on the ALS Functional Rating Scale (ALSFRS-R, Cedarbaum1999) speech sub-score and/or score of 2, 1, or 0 ALSFRS-R handwriting sub-score.
Continuous use of face-mask noninvasive ventilator that would impair comfortable wearing of AVP headset for at least 60 minutes
History of visual impairment incompatible with device use
History of medical diagnoses that could be exacerbated by use of the augmented reality headset: uncontrolled migraines or chronic headache, dizziness, vertigo, or other inner ear conditions, dry eyes, skin allergies, seizures
Diagnosis of frontotemporal dementia or other severe cognitive impairment that is sufficient, in the opinion of the study neurologist, to interfere with the subject’s ability to provide informed consent and reliably complete questionnaires
ALL ALS-ASSESS
This study will follow symptomatic ALS participants and control participants for 2 years, measuring a wide range of ALS outcome measures and gathering long term survival data.
Study visits will be conducted both in an in-clinic setting (on-site) and remotely (off-site) over the course of 24 months (2 years). The symptomatic ALS cohort participants can either participate in on-site or off-site visits, depending on their location and ease of access to one of the participating sites.During this 2-year period, symptomatic ALS participants will complete a screening visit (2-3 hours to complete), a total of 7 in-person study visits (1-3 hours to complete) and 24 remote self-assessment activities (completed each month, takes 35-45 minutes to complete). Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study. All control participants will participate on-site, completing their on-site visits every 12 months.Biospecimens will be collected at regular intervals to support biofluid biomarker analyses. Biospecimens will include plasma, serum, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF). For on-site symptomatic ALS and control participants, CSF will be collected through optional Lumbar Puncture (LP) procedure. Only plasma, serum and whole blood will be collected for off-site participants through home phlebotomy collection process.
Up to $350
Capable of providing informed consent
Willing to follow study procedures
Diagnosis of ALS by a physician
Access to a smartphone, computer or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Clinically significant unstable medical condition (other than ALS) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator’s judgment.
Optional Lumbar Puncture - Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
ALL ALS-PREVENT
The primary purpose of this study is to collect samples and health information from individuals who are genetically at risk for ALS to better understand ALS and how the disease progresses.
Study visits will be conducted both in an in-clinic setting and remotely with 14 visits over the course of 36 months (3 years). Participants will complete a total of 10 visits over the course of 36 months (3 years). There will be a screening visit onsite in the clinic; 3 in-person onsite clinic visits once a year; and 6 remote visits once every 4 months. Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study.Biospecimens will be collected alongside COA to support biofluid biomarker analyses. Biospecimens will include plasma, serum, RNA, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF) via lumbar puncture (LP). To supplement annual in-person visits, participants will undergo additional biofluid collection (plasma, serum and whole blood) which will be remotely collected through home phlebotomy.
Up to $780
Capable of providing informed consent and willing to follow study procedures.
First-degree relative of known carrier of ALS gene OR First-degree relative of individual with ALS and/or FTD in a family with a “compelling family history” of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members.
Access to a smartphone, computer, or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Genetic Testing Sub-Study: Currently enrolled in the PREVENT ALS Study
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression that would interfere with the study procedure.
Clinically significant, unstable medical condition that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.
Optional Lumbar Puncture: Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Genetic Testing Sub-Study: Presence of unstable psychiatric illness (psychosis, active suicidal ideation, suicide attempt, or untreated major depression) in whom predictive genetic testing would confer a high risk of harm.
Clinical Decision Making
This study investigates how clinicians (medical students) assess pain during simulated patient interactions. Participants will watch videos depicting patients with varying pain levels, while their brain activity is monitored using functional Magnetic Resonance Imaging (fMRI). The research aims to understand the neurological and behavioral responses in clinical decision making enhancing our knowledge of clinical practices and patient care.
Participants will complete pre-visit questionnaires at home, engage in simulated clinical interactions during a single lab visit fMRI session, and fill out post-visit questionnaires immediately after the MRI. This study is designed to assess their clinical decision-making in response to pain scenarios.
250-400
2.Currently enrolled as either 4th-year medical students at Hershey Medical Campus or University Park, or pre-medical students who have been accepted into a medical program for the 2024 academic year.
3.No reported substance abuse within the past year.
4.Capable of performing experimental tasks, including speaking and reading English, following instructions, and tolerating an fMRI scan.
5.Fluent or native English speakers.
2.Inability to tolerate scanning procedures, including claustrophobia.
3.Presence of metal in the body or a history of working with metal fragments that pose a risk in MRI environments.
4.Contraindications for MRI examination, such as metallic implants, pacemakers, surgical aneurysm clips, nicotine patches, or known metal fragments in the body.
5.History of neurological or systemic disorder that could impair cognitive function.