Clinical Trials Logo

Clinical Trial Summary

Background: When people have a stroke, they often have difficulty moving their arms and hands. Transcranial magnetic stimulation (TMS) can improve how well people with and without stroke can move their arms and hands. But the effects of TMS are minor, and it doesn t work for everyone. Researchers want to study how to time brain stimulation so that the effects are more consistent. Objective: To understand how the brain responds to transcranial magnetic stimulation so that treatments for people with stroke can be improved. Eligibility: Adults ages 18 and older who had a stroke at least 6 months ago Healthy volunteers ages 50 and older Design: Participants will have up to 5 visits. At visit 1, participants will be screened with medical history and physical exam. Participants with stroke will also have TMS and surface electromyography (sEMG). For TMS, a brief electrical current will pass through a wire coil on the scalp. Participants may hear a click and feel a pull. Muscles may twitch. Participants may be asked to do simple movements during TMS. For sEMG, small electrodes will be attached to the skin and muscle activity will be recorded. At visit 2, participants will have magnetic resonance imaging (MRI). They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noise. At visit 3, participants will have TMS, sEMG, and electroencephalography (EEG). For EEG, small electrodes on the scalp will record brainwaves. Participants will sit still, watch a movie, or do TMS. Participants may be asked to have 2 extra visits to redo procedures.


Clinical Trial Description

Study Description: We will study if corticospinal excitability, intracortical inhibition and intracortical facilitation vary across different sensorimotor alpha and beta electroencephalography (EEG) waveform oscillation phases in healthy adults and chronic stroke patients. In young healthy adults, sensorimotor cortical neuronal spiking is highest at sensorimotor alpha oscillation troughs and lowest at sensorimotor alpha oscillation peaks. Short interval cortical inhibition (SICI) is unaffected by alpha phase, consistent with alpha phase representing a form of transient, pulsed excitation, unaffected by gamma-aminobutyric acid (GABA)-mediated inhibition. In contrast to sensorimotor alpha, motor evoked potential (MEP) amplitudes are not maximal at the trough phase of the sensorimotor beta rhythm. Objectives: TMS is a potential adjunct therapy for post-stroke neurorehabilitation. So far, it has been customarily applied uncoupled from brain oscillatory activity, resulting in variability in the biological response to each stimulus, small effect sizes and significant inter-individual variability. Alpha band oscillatory activity is linked to cortical excitation and inhibition, motor function and cognitive processing. It is possible that TMS effects could be more consistent when applied to specific phases or phase angles of ongoing brain oscillatory activity. For example, corticospinal excitability (as measured with TMS) in healthy humans varies depending on the sensorimotor alpha and beta oscillatory phase during which TMS is delivered. There is no information available on intracortical facilitation and inhibition as a function of beta phase angle in healthy humans. In Experiments 1 and 3 we have been assessing alpha phase-dependent corticospinal excitability measures. In Experiment 2, we will assess beta and secondarily alpha phase-dependent intracortical inhibitory and facilitatory circuits in young and older adults. Endpoints: For experiments 1 and 3, the primary outcome measure is corticospinal excitability. For Experiment 2, the primary outcome is SICI. Exploratory outcome measures may include MEP amplitude variability, SICI, short intracortical facilitation (SICF) and intracortical facilitation (ICF) and TMS-induced oscillations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03288220
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact Tasneem F Malik, C.R.N.P.
Phone (301) 451-1335
Email tasneem.malik@nih.gov
Status Recruiting
Phase
Start date September 11, 2018
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1