N/A N=13 Randomized Single-blind Basic Science

Modulating the Hippocampal and Striatal Memory Networks With rTMS

Normal Behavioral Patterns

Bottom Line

View on ClinicalTrials.gov: NCT03994120 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Change From Baseline in Resting-state Functional Connectivity Between the Caudate and the Caudate Network — -0.073; -0.021; -0.029; -0.007 Fisher Z-Transformation Score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RTMS (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Resting-state Functional Connectivity Between the Caudate and the Caudate Network	-0.073; -0.021; -0.029; -0.007	—
PRIMARY Change From Baseline in Task-based Functional Connectivity Between the Caudate and the Caudate Network	0.028; -0.083; 0.121; -0.026	—
SECONDARY Feedback Weather Prediction Task (WPT-F)	0.003; -0.109; -0.040; -0.198	—
SECONDARY Observational Weather Prediction Task (WPT-O)	-0.026; -0.150; -0.005; -0.027	—
SECONDARY Change From Baseline in Resting-state Functional Connectivity Between the Caudate and the Hippocampal Network	-0.054; -0.049; -0.093; -0.024	—
SECONDARY Change From Baseline in Task-based Functional Connectivity Between the Caudate and the Hippocampal Network	0.027; -0.066; -0.168; 0.034	—

Summary

Background: People have 2 memory systems. One helps them learn skills and the other helps them learn facts. Repetitive transcranial magnetic stimulation (rTMS) uses electric currents to activate brain cells. This can make small changes in how brain systems operate. Researchers will use rTMS to change how memory systems work and to see if changing one system causes the other to change too. This could help find ways to improve learning and memory in people with memory disorders. Objective: To learn how different memory systems work with each other. Eligibility: Healthy adults ages 18-40 who are not pregnant Design: Potential participants will be screened with a neurological exam if they have not had one from NINDS in the past 2 years. They may have urine tests. Eligible participants will have 5-10 visits at NIH. Each visit will last 1-6 hours. Visits 1-4 will each take place 1 day apart. At visit 1, participants will have an MRI and take memory tests. For MRI, they will lie on a table that slides in and out of a cylinder that takes pictures of their brain. They will also have rTMS. For rTMS, a metal coil is held on their scalp. Brief electrical currents pass through the coil. At visits 2 and 3, participants will have rTMS. At visit 4, participants will have an MRI and do memory tests. About a week later, participants will have visit 5. They will have an MRI and do memory tests. Participants may be asked to have more visits if any technical problems occur. Participant involvement will last 2 weeks. ...

Eligibility Criteria

INCLUSION CRITERIA

-Age 18-40 (inclusive)

EXCLUSION CRITERIA

Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson disease, Alzheimer disease, schizophrenia or major depression
History of seizure
Medications acting on the central nervous system, such as those that lowers the seizure threshold such as neuroleptics, beta lactams, isoniazid, metronidazole; benzodiazepines, tricyclic or other antidepressants; or prescription stimulants.
Ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body
Implanted cardiac pacemaker or auto-defibrillator or pump
Non-removable body piercing
Claustrophobia
Inability to lie supine for 2 hours
Pregnancy, or plans to become pregnant during the study.
Members of the NINDS BNU
Subjects that received rTMS under protocol 17-N-0055 are excluded in order avoid learning effects from previously being exposed to the same behavioral tasks
Subjects who have contraindications to MRI (we will follow the NMR Center guidelines for MR safety). Some of the exclusions are:
Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity as these make having an MRI unsafe.
Unable to lie flat on the back for the expected length of the experiment (2 hours).
Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis.
Non-removable body piercing or
Pregnancy (urine pregnancy test)

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Data sourced from ClinicalTrials.gov (NCT03994120). 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.