Healthy Volunteers Clinical Trial
Official title:
Loss of Depotentiation in Focal Dystonia
Background
Focal dystonia is a brain disorder. It affects a muscle or muscles in a specific part of the
body. Researchers think it may be related to excessive training or practice. They want to
know more about how much training might trigger focal dystonia.
Objectives:
To study why people develop focal dystonia. To study how brain plasticity changes with focal
dystonia.
Eligibility:
People at least 18 years of age with focal dystonia.
Healthy volunteers the same age are also needed.
Design:
Participants will be screened with a physical exam and questions. They may have blood and
urine tests.
Participants will have up to 3 testing visits.
Participants will have small electrodes stuck on the skin on the hands or arms. Muscle
activity will be recorded.
Participants will have transcranial magnetic stimulation (TMS). A wire coil will be placed
onto the scalp. A brief electrical current will pass through the coil. The current will
create a magnetic field that affects brain activity.
Participants may be asked to tense certain muscles or do simple actions during TMS.
A nerve at the wrist will get weak electrical stimulation. The stimulation may be paired with
TMS for very short times.
Participants will receive repeated magnetic pulses. Participants will receive a total of 150
pulses during a 10-second period. An entire testing visit will last about 3 hours.
...
Objectives
Simulation paradigms can induce plastic changes in brain excitability. Paired associative
stimulation (PAS) with an interstimulus interval of 25 ms (PAS25) induces a long-term
potentiation (LTP)-like effect while that at an interval of 10 ms (PAS10) induces a long-term
depression (LTD)-like effect. The LTP-like effect induced by PAS25 is exaggerated in patients
with focal dystonia. The LTD-like effect with PAS10 is also increased in focal dystonia but
not in the target area of PAS. Depotentiation refers to the reversal of LTP by which LTP is
abolished by a following procedure that has no effect when it is given alone. Brain-derived
neurotrophic factor has a variety of roles in modulating both LTP and LTD. The Val66Met
single nucleotide polymorphism is related to abnormal cortical plasticity. In this protocol,
we propose a study to test the hypothesis that depotentiation is weaker in focal dystonia
patients compared to healthy controls. In addition, motor cortical inhibition is decreased in
focal dystonia. We will test the changes in motor cortical inhibition following different
interventional procedures in focal dystonia. We will also test the relationship between
depotentiation and LTP/LTD-like effects in focal dystonia patients.
Study population
We intend to study up to 20 patients with focal dystonia and 20 age-matched healthy
volunteers. Subjects will complete up to 3 study visits involving 3 different interventional
procedures. Various outcome measures will be performed during each study visit.
Design
This is a hypothesis-driven study. We will compare the depotentiation effect in patients with
focal dystonia to that in healthy volunteers. Patients will be evaluated with a clinical
rating scale during the screening visit. Three interventional procedures will be tested
during three study visits. Specifically, PAS25-cTBS150 tests the primary hypothesis with a
depotentiation effect. PAS25 tests LTP-like effect and PAS10 tests the LTD-like effect. We
will investigate the difference in outcome measures between patients and healthy volunteers
after the interventional procedures. We will perform genetic tests to identify the
brain-derived neurotrophic factor genotype in the patients and healthy volunteers.
Outcome measures
The primary outcome measure is motor-evoked potential (MEP) induced by transcranial magnetic
stimulation immediately after the interventional procedure of PAS25-cTBS150. We will compare
MEP amplitude in patients with that in healthy volunteers to identify whether depotentiation
is weaker in focal dystonia. The secondary outcome measures are MEP amplitudes at other time
points after the PAS25-cTBS150 procedure. We will also perform exploratory studies to
investigate the effects of interventional procedures of PAS25 and PAS10 alone. We will test
the relationship between depotentiation and LTP/LTD-like effects in focal dystonia. We will
also study other exploratory outcome measures such as: resting and active motor threshold,
MEP recruitment curve, excitability of motor cortical circuits (short- and long-interval
intracortical inhibition, and intracortical facilitation) after three different
interventional procedures.
;
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 |