Status:
WITHDRAWN
Effects of PrTMS on Performance
Lead Sponsor:
West Virginia University
Conditions:
Sleep Quality
Cognition Improvement
Eligibility:
All Genders
18-42 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the ability of a form of non-invasive brain stimulation called personalized repetitive transcranial magnetic stimulation, or PrTMS, to enhance cognitive performa...
Detailed Description
Repetitive Transcranial Magnetic Stimulation (rTMS) is an FDA approved, non-invasive, non-pharmaceutical strategy for treating adults with major depression. This particular treatment strategy is also ...
Eligibility Criteria
Inclusion
- Male or female between 18-42 years of age.
Exclusion
- • Unable/unwilling to commit to participating in 1x per day treatments for 6 consecutive weeks
- Outside of the age range of 18-42
- Currently undergoing hormone therapy
- History of blood clotting disorder
- History of open skull traumatic brain injury
- History of clinically significant seizure disorder
- History of clinically significant manic episodes
- Diagnosed with Diabetes Mellitus
- Individuals with a clinically defined neurological disorder including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Cerebral aneurysm
- Has participated in any type of rTMS treatment within 3 months prior to the screening visit
- Currently receiving antipsychotic or anticonvulsant medication treatment
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
- Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning
- History of psychosis
- History of migraines
- Current thoughts of suicidal ideation or self-harm
- Substance use disorder within the past six months
- Those pregnant or actively trying to become pregnant
- Intake of one or a combination of the following drugs forms a 'Strong Potential Hazard' for application of rTMS due to their significant seizure threshold lowering potential:
- Imipramine
- Amitriptyline
- Doxepine
- Nortriptyline
- Maprotiline
- Chlorpromazine
- Clozapine
- Foscarnet
- Ganciclovir
- Ritonavir
- Amphetamines
- Cocaine (MDMA, ecstasy)
- Phencyclidine (PCP, angel's dust)
- Ketamine
- Gamma-hydroxybutyrate (GHB)
- Alcohol
- Theophylline
- Note: Being on one of these medications or substances would not automatically exclude a participant from study participation. The risk is dependent on the patient's past medical history, drug dose, speed of dose increase (or decrease), history of recent medication changes or duration of treatment, and combination with other CNS active drugs. Considering all the variables and keeping participant safety in mind, if a potential participant is on any of the above medication, the participant will be carefully evaluated and a justification for the decision to include them in the study will be documented by the medically responsible physician.
- Recent withdrawal from one of the following drugs forms a 'Strong Relative Hazard' for application of rTMS due to the resulting significant seizure threshold lowering potential:
- Alcohol
- Barbiturates
- Benzodiazepines
- Meprobamate
- Chloral hydrate
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05353244
Start Date
December 4 2023
End Date
December 4 2023
Last Update
January 17 2024
Active Locations (1)
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1
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States, 26505