Healthy Volunteers Clinical Trial
Official title:
Interhemispheric Interaction of Parieto-Motor Cortico-Cortical Plasticity in Human Brain
Background:
The two hemispheres of the brain are connected. Changes in one hemisphere affect the other
through this connection. Research has shown that training new skills in one hand improves the
same skills for the other hand. Researchers want to learn more about how the brain works to
transfer the skills to the other hand.
Objective:
To learn how changes on one side of the brain affect the other side. To study the activity of
the left and right sides of the brain in healthy adults.
Eligibility:
Healthy volunteers ages 18-55 years old who are right-handed.
Design:
Participants will be screened with a medical history and physical exam. They will complete a
questionnaire about their handedness. This may be done on paper or on a computer.
Participants may have urine pregnancy tests.
Participants will have 2 study visits.
Participants will have a structural magnetic resonance imaging (MRI) scan. MRI uses a strong
magnetic field and radio waves to take pictures of the brain. The scanner is a metal cylinder
in a strong magnetic field. Participants will lie on a table that slides in and out of the
cylinder.
Participants will have transcranial magnetic stimulation (TMS). Two wire coils will be placed
on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse
that affects brain activity. Participants may be asked to tense certain muscles or do simple
tasks during TMS.
Participants will have electromyography. Small sticky pad electrodes will be attached to the
skin on the hands. Muscle activity will be recorded during the TMS procedure.
Objective:
The purpose of this study is to evaluate the effect of long-term potentiation (LTP)-like
cortical plasticity induced by parieto-motor cortico-cortical paired associative stimulation
(cc-PAS) on the contralateral hemisphere and interhemispheric interactions in normal brain
using dual-site transcranial magnetic stimulation (TMS). We will explore the ipsilateral and
contralateral effects of cc-PAS over the left primary motor cortex (M1). We hypothesize that
the motor evoked potential (MEP) at S50 (the motor evoked potential) will change after cc-PAS
in the left hemisphere, which stimulates M1 after PPC (effective cc-PAS), not only on the
right first dorsal interosseous (FDI) muscle, but also the left FDI muscle.
In addition, we hypothesize that the MEP at S50 will change after cc-PAS in the left
hemisphere, which stimulates PPC after M1 (ineffective cc-PAS), on the right FDI muscle but
not the left FDI muscle.
Study population
We intend to study 15 healthy-volunteers to have 12 who complete the study. Subjects will
complete up to one screening visit and two study visits involving two intervention.
Design
Subjects will come for one screening visit and two outpatient study visits. The screening
visit and the first study visit can be performed the same day. The second study visit will be
done approximately 1 week after the first one. TMS-induced electromyographic (EMG) activity
of hand muscles will be recorded as MEPs. Using single TMS measure on both the left and right
M1, we will measure MEPs and input-out (I-O) curve for the right and left FDI muscle and
abductor digiti minimi (ADM) muscle, respectively. Using a paired-pulse TMS paradigm,
interhemispheric inhibition (IHI) from the left M1 to the right M1, short-interval
intracortical inhibition (SICI) and intracortical facilitation (ICF) will be measured on the
left FDI and ADM muscles. Then, the subjects will undergo two plasticity induction procedures
of the parieto-motor cc-PAS sessions. One of those is the hypothesized efficacious cc-PAS
session and the other one is the control, a hypothesized ineffective cc-PAS session. The two
sessions will be separated by approximately one week. Each session consists of 100 pairs of
double stimulation to the left PPC and left M1. MEPs, I-O curve on the bilateral M1, IHI from
the left M1 to the right M1, SICI and ICF will be remeasured during the 60 min after
receiving cc-PAS.
Outcome measures
Primary outcome:
The primary outcome measure will be MEP amplitude from the bilateral M1 with respect to time
(before, immediately and 30-45 min after intervention) after induction of cc-PAS plasticity
over the left hemisphere in each session. The amplitude of MEPs on each side of M1 will be
compared between before and after cc-PAS with respect to time, using ANOVA in each session.
Secondary outcome:
The degree of IHI from the left M1 to the right M1, SICI and ICF with respect to time
(before, immediately and 30-45 min after intervention) will be compared by the ANOVA test.
The degree of IHI and the change of IHI will be correlated with the primary outcome as
measured with a correlation analysis.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
| Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
| Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
| Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
| Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
| Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
| Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
| Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
| Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
| Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
| Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
| Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
| Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
| Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
| Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |