Beta Events and Sensory Perception
Beta Rhythm · Tactile Perception
Bottom Line
View on ClinicalTrials.gov: NCT04062318 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online Active SI-Hand TMS (Device); Online Sham SI-Hand TMS (Device); Online Active Control TMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Threshold-Level Tactile Detection Hit Rate |
0.37; 0.46; 0.47; 0.32; 0.41; 0.42 | 0.0031 sig |
| SECONDARY EEG Tactile Evoked Response Potential (ERP) |
-0.7937; -0.2330; -1.3684; -0.8988; 0.0562; 0.0727 | 0.0333 sig |
Summary
Eligibility Criteria
Inclusion Criteria
- Ability to provide informed consent/assent
- Age: 18-65 years
- English fluency: participants must be able to understand screening questionnaires and task instructions spoken/written in English.
- Right handed: to reduce heterogeneity related to hand dominance, since our task involves touch perception on the hand, and examination of neural correlates in lateralized brain regions.
Exclusion Criteria
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Any progressive (e.g., neurodegenerative) neurological disorder
- Chronic medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Metal implants (excluding dental fillings)
- Pacemaker
- Implanted medication pump or cochlear implant
- Vagal nerve stimulator
- Deep brain stimulator
- TENS unit (unless removed completely for the study)
- Ventriculo-peritoneal shunt
- Signs of increased intracranial pressure
- Intracranial lesion
- History of head injury resulting in prolonged loss of consciousness
- Pregnancy
- Participants who have received prior TMS for medical treatment purposes.
- Intellectual Disability or autism spectrum disorder (ASD)
- Active psychosis, diagnosis of unipolar depression or bipolar disorder, active severe substance use disorders (within the last month), or active suicidal intent or ideations.
- Conditions that may result in the inability to effectively carry out the tactile detection task, including loss of feeling, neuropathy or nerve damage in the hands or feet, chronic pain or fibromyalgia, and pain due to cancer, infection or arthritis.
- If the participant is actively taking any of the medications that increase risk from TMS as indicated below, of if they have ingested any alcohol or any other drugs of abuse (see https://www.drugabuse.gov/drugs-abuse) on the day of the study session (prior to the session).
Contraindicated medications:
alcohol Amitriptyline Amphetamines ampicillin Anticholinergics Antihistamines aripiprazole BCNU **bupropion** cephalosporins chlorambucil chloroquine Chlorpromazine citalopram Clozapine Cocaine cyclosporine cytosine arabinoside Doxepine duloxetine fluoxetine fluphenazine fluvoxamine Foscarnet gamma-hydroxybutyrate (GHB) Ganciclovir haloperidol imipenem Imipramine isoniazid ketamine levofloxacin Lithium Maprotiline MDMA (ecstasy) mefloquine methotrexate metronidazole mianserin mirtazapine Nortriptyline olanzapine paroxetine penicillin phencyclidine (PCP, angel's dust) pimozide quetiapine reboxetine risperidone Ritonavir **Sertraline** Sympathomimetic theophylline venlafaxine vincristine ziprasidone
Data sourced from ClinicalTrials.gov (NCT04062318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.