Modulating the Hippocampal and Striatal Memory Networks With rTMS

NCT03994120 | Completed Results

• 2 other identifiers: 19011419-N-0114
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

Normal Behavioral Patterns

Keywords

Memory Systems; Repetitive Transcranial Magnetic Stimulation; Behavioral Efficiency; Hippocampal and Striatal Memory Networks

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Resting-state Functional Connectivity Between the Caudate and the Caudate Network

  Participants underwent repetitive transcranial magnetic stimulation (rTMS) to the caudate network, which supports learning skills. rTMS uses electric currents to activate brain cells, which can temporarily change brain connections and memory. We measured how rTMS affects caudate network brain connectivity. These changes were observed with MRI. To measure brain connection strength, we calculated how closely neural activity correlates in the caudate network. We measured how rTMS affects connection strength before and 1 day after stimulation (immediate effects), and before and 14-21 days after stimulation (long-term effects) and then calculated the change as a Z-transformation score. A change in the Fisher Z-transformation correlation coefficient score of 0 suggests no difference in the connections between brain areas after rTMS; a score of \< 0 suggests a weakening of the connections between brain areas; and a score of \> 0 suggests a strengthening of the connections between brain areas.

  Baseline, 1 day and 14-21 days after rTMS

• Change From Baseline in Task-based Functional Connectivity Between the Caudate and the Caudate Network

  Participants underwent repetitive transcranial magnetic stimulation (rTMS) to the targeted memory network, i.e., caudate network. rTMS uses electric currents to activate brain cells, which can temporarily change brain connections and memory. We measured how rTMS affects caudate network brain connectivity on MRI during a Weather Prediction Task. To measure brain connection strength, we calculated how closely neural activity correlates in the caudate network. We measured how rTMS affects connection strength and skill learning by measuring them before and 1 day after stimulation (immediate effects), and before and 14-21 days after stimulation (long-term effects) and then calculated the change as a Z-transformation score. A change in the Fisher Z-transformation score of 0 suggests no difference in the connections between brain areas; a score of \< 0 suggests a weakening of the connections between brain areas; and a score of \> 0 suggests a strengthening of connections between brain areas.

  Baseline, one day and 14-21 days after rTMS

Secondary Outcomes (4)

• Feedback Weather Prediction Task (WPT-F)

  Changes are calculated before and one day after rTMS and before and 14-21 days after rTMS

• Observational Weather Prediction Task (WPT-O)

  Changes are calculated before and one day after rTMS and before and 14-21 days after rTMS

• Change From Baseline in Resting-state Functional Connectivity Between the Caudate and the Hippocampal Network

  Baseline, one day and 14-21 days after rTMS

• Change From Baseline in Task-based Functional Connectivity Between the Caudate and the Hippocampal Network

  Baseline, one day and 14-21 days after rTMS

Study Arms (3)

Motor Cortex rTMS

ACTIVE COMPARATOR

Motor Cortex rTMS

Other: RTMS

PPC rTMS

ACTIVE COMPARATOR

PPC rTMS

Other: RTMS

vertex rTMS

PLACEBO COMPARATOR

vertex rTMS

Other: RTMS

Interventions

RTMS OTHER

Altering the connectivity of trans-synaptic pathways

Motor Cortex rTMS; PPC rTMS; vertex rTMS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 (inclusive)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Results Point of Contact

• Title: Dr. Eric Wasserman
• Organization: National Institutes of Health/NINDS

wassermanne@ninds.nih.gov

301-495-0151

Study Officials

• Eric M Wassermann, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: September 26, 2019
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: July 6, 2022
• Results First Posted: June 14, 2022

Record last verified: 2021-05

Locations

US (1)