| NCT ID | NCT07660601 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2028-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-01-31 with a primary completion date of 2028-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot study proposes a clinical trial to target treatment of sensorimotor and cognitive deficits in persons with Multiple Sclerosis (pwMS). The proposal has the potential to promote neuroplasticity and induce re-normalization in brain to muscle (cortico-muscular) connectivity (BMC) and within brain connectivity via an integrative training approach. Preliminary data and published work are available to inform specific aspects of the proposed trial, along with the general rationale for exploring the suggested rehabilitation approach. However, there is a gap in research on the effects of training that uses the proposed approach via a clinical trial (of any phase) in pwMS to support the rationale for exploring the suggested rehabilitation training approach. Moreover, there is no pilot data on the training itself in the same population. This study will examine the behavioral deficits and neural characteristics in children with MS and two other related conditions (Myelin Oligodendrocyte Glycoprotein (MOG) and Nueromyelitis Optica Spectrum Disorder (NMOSD)) to understand if they would benefit from rehabilitation training conditions tested in aims 1 and 2. The overall long term goal is to improve rehabilitation training conditions for both adults and children with MS.
Eligibility Criteria
Inclusion Criteria: * Age 18 to 80 yrs Clinically definite MS diagnosis Ability to attend to computer screen and follow instructions in English which will be assessed by MiniMental test requiring a participant to score \>24 (out of 30 max score) Right-handed as determined by research diagnostic criteria of the Edinburgh Handedness Inventory (Oldfield 1971) Self report of normal or corrected-to-normal vision Exclusion Criteria Psychiatric disorders, only those requiring treatment because the medications may affect brain activation Neurological disorder that may affect cognition, balance, and/or physical wellness such as brain injury, or stroke. Orthopedic injuries or neuromuscular disorder that may affect balance or mobility Engagement in other cognitive or physical training program while enrolled in this study Ongoing relapse (new or returning neurological symptoms) or steroid treatment during the 30 days preceding enrollment
Contact & Investigator
Soha Saleh, PhD
PRINCIPAL INVESTIGATOR
Rutgers University
Frequently Asked Questions
Who can join the NCT07660601 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07660601 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07660601 currently recruiting?
Yes, NCT07660601 is actively recruiting participants. Contact the research team at soha.saleh@rutgers.edu for enrollment information.
Where is the NCT07660601 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT07660601 clinical trial?
NCT07660601 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Soha Saleh, PhD at Rutgers University. The trial plans to enroll 30 participants.