Influence of Brain Oscillation-Dependent TMS on Motor Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18 years to less than 50 years. (18 to 49)
Willingness/ability to provide informed consent.
Ability to induce a motor evoked potential in the muscle target of the upper extremity, as evaluated during the TMS Screening.
Age 50 and over
Disqualifiers
Presence of severe neurological or medical disorder (e.g., Parkinson s disease or multiple sclerosis).
History of seizures.
Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), tri-cyclic or other anti-depressants, benzodiazepines, or prescription stimulants.
Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside the eye or skull.
Trial population
Experiment 1: Up to 24 older healthy volunteers (ages 50 and older). Experiment 2 (added in October 2023): Up to 31 young healthy adults (18-49) and 31 older healthy adults (50 and older). Experiment 3: Up to 28 stroke patients (age 18 and older). Total: up to 114 participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
114 Participants
are grouped into 2 trial groupsGroup A: Healthy volunteers
Group B: Stroke patients
Trial outcomes
Primary outcomes
1
We will study if corticospinal excitability varies across different sensorimotor alpha EEG waveform oscillation phases in healthy older adults and chronic stroke patients with weakness in one or both arms.
For both experiments, the primary outcome measure is corticospinal excitability. Exploratory outcome measures include MEP amplitude variability, and TMS-induced oscillations
Time frame
6 yearsSponsors and contacts
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Source ClinicalTrials.gov