Brain State-dependent Stimulation to Improve Movement
Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool to non-invasively modulate brain circuits, brain plasticity, and behavior. This proposal will test the hypothesis that controlling behavioral state during focal multi-day rTMS of a brain region involved in grasping movements will enhance the functional specificity of the neuromodulation action among distributed brain regions involved in voluntary motor control and concomitantly improve manual dexterity. Results from this study will be used to optimize rTMS therapy for individuals with neuromotor impairments by controlling behavioral state to improve the efficacy of rTMS treatment. Healthy volunteers that qualify for this study will have motor skill assessments and basic neuromotor testing (using neurophysiology with TMS and functional Magnetic Resonance Imaging (fMRI) scans). Participants will be asked to come in for up to nine sessions that include 1 screening session, 5 consecutive daily rTMS sessions and 3 assessment sessions with resting-state and task-based fMRI, neurophysiology with TMS, and hand motor tasks over the course of 3-4 weeks.
Conditions:
🦠 Healthy
🗓️ Study Start (Actual) 15 February 2022
🗓️ Primary Completion (Estimated) July 2024
✅ Study Completion (Estimated) July 2024
👥 Enrollment (Estimated) 65
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Women of child bearing age cannot be pregnant or trying to become pregnant
    • * Ability to tolerate small, enclosed spaces without anxiety
    • * Ability and willingness to give informed consent to participate
    • * No history of neurological disorder
    • * Right handed
    • * English speaking

    Exclusion Criteria:

    • * Are left-handed
    • * Are younger than 18 or older than 50 years old
    • * Women who are pregnant, suspect they are pregnant, or are attempting to become pregnant
    • * Have metal anywhere in the head, excluding the mouth
    • * Have a pacemaker, deep brain stimulator, vagus nerve stimulator or any other medically implanted device
    • * Have cochlear hearing implants
    • * Are taking GABAergic, NDMA-receptor antagonist, or other drug known to influence neural receptors
    • * Have any of the below conditions that would put participants at increased risk of having a seizure: a personal or family history of seizure/epilepsy, taking prescription drugs that lower the threshold for seizures, recent history of excessive alcohol consumption, history of alcohol addiction/dependence, recent history of recreational drug use, history of drug addiction/dependence
    • * Have been diagnosed with any of the following: a stroke, brain hemorrhage, brain tumor, encephalitis, multiple sclerosis, Parkinson's disease or Alzheimer's disease, depression in the past 6 months, attention deficit disorder, schizophrenia, manic depressive (bipolar) disorder, normal pressure hydrocephalus or increased intra-cranial pressure, diabetes requiring insulin treatment, any serious heart disorder or liver disease
    • * Have had a migraine in the past month
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 October 2021
  • First Submitted that Met QC Criteria 1 November 2021
  • First Posted 2 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 August 2023
  • Last Update Posted 21 August 2023
  • Last Verified August 2023