Functional Connectivity as a Biomarker of rTMS
2 other identifiers
interventional
68
1 country
1
Brief Summary
Background: Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help improve connections between brain areas in healthy people. Researchers want to see if it can be useful in patients with memory problems after TBI. Objective: To see how repetitive transcranial magnetic stimulation can be used to improve the connections between parts of the brain and whether this will lead to changes in memory. Eligibility: Adults 18-50 years old with TBI who can speak and write in English. Healthy volunteers the same age and English ability. Design: Participants will be screened with a neurological exam and may have a urine pregnancy test. Participants with TBI will have 7-15 visits. Healthy volunteers will have 2-8 visits. At the visits, participants will have all or some of the following:
- MRI for about 1 hour. Participants will lie in a machine that takes pictures in a magnetic field. Participants will do some memory tasks.
- Memory and attention tasks with pictures and with a computer
- Questions about their mental state and well-being
- TMS: A wire coil is held on the scalp and a short electrical current passes through it. Participants will hear a click and feel a pulling or twitch. They may be asked to make simple movements. rTMS is repeated magnetic pulses in short bursts. They will have this for about 20 minutes. A week after the last visit, some participants will return for a memory test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedStudy Start
First participant enrolled
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2020
CompletedResults Posted
Study results publicly available
April 12, 2021
CompletedApril 12, 2021
June 1, 2020
3 years
February 10, 2017
February 11, 2021
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Functional Connectivity (FC) Changes Between the Left Hippocampus and Left Parietal Cortex
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at sufficient intensity to trigger action potentials in nearby neurons.The motor threshold is defined as the minimum percentage of the stimulator output to elicit a motor evoked potential. Repetitive TMS (rTMS) was delivered at 100% of the motor evoked potential threshold with repeated magnetic pulses at a frequency of 20 Hz. Functional MRI (fMRI) measures the change in oxygenated blood in the brain; at rest these levels fluctuate over time. These fluctuations can be similar between different parts of the brain. FC is the similarity in fluctuations of these fMRI signals and suggest how strongly two regions communicate with each other. We measured how TMS can change FC between specific areas of the brain. A positive score suggests a stronger communication between regions of the brain.
Changes are calculated before and the day after rTMS
Associative Memory Test Score Changes
Participants studied 20 face-word pairs, and after a short delay, were required to recall the word associated with each pair. The number of correctly remembered pairs was recorded. rTMS was administered over different regions of the brain over 3 days. The Associative Memory test was administered at baseline (within a week before the first rTMS session), 1 day after the last rTMS session, and again 7-14 days after the last rTMS session. We calculated improvements on this task by subtracting the number of successfully remembered pairs 1 day after stimulation from the number remembered at baseline ("Changes one day after rTMS"). We also calculated whether these improvements lasted longer by subtracting the number of successfully remembered pairs 7-14 days after stimulation from the number remembered at baseline ("Changes 7-14 days after rTMS"). Positive scores represent increases in associative memory.
Changes are calculated before and the day after rTMS and before and 7-14 days after rTMS
Secondary Outcomes (1)
Implicit Weather Prediction Task (WPT)
Changes are calculated before and the day after rTMS, and before and 7-14 days after rTMS
Study Arms (6)
Parietal Cortex rTMS stimulation - 1 day
EXPERIMENTALExperiment 1
Parietal Cortex rTMS stimulation - 3 days
EXPERIMENTALExperiment 1
Parietal Cortex rTMS stimulation - 4 days
EXPERIMENTALExperiment 1
Experiment 2 - Parietal Cortex rTMS stimulation - 3 days
EXPERIMENTALExperiment 2
Experiment 2 - Vertex rTMS stimulation - 3 days
EXPERIMENTALExperiment 2
Experiment 2 - Prefrontal Cortex rTMS stimulation - 3 days
EXPERIMENTALExperiment 2
Interventions
Altering the connectivity of trans-synaptic pathways
Eligibility Criteria
You may qualify if:
- Experiments 1 and 2:
- Healthy individuals
- Age 18-50 (inclusive)
- English speaking and writing
- Experiment 3:
- Age 18-50 (inclusive)
- English speaking and writing
- History of mild to moderate TBI
- Performance 1 standard deviation below age-adjusted population norms on the
- CVLT-2 within the past year from the date of visit.
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
- 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 1 hour
- Pregnancy, nursing, or plans to become pregnant during the study.
- Members of the NINDS Behavioral Neurology Unit (BNU)
- For Experiment 2: Participation in Experiment 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.
PMID: 25170153BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Eric Wassermann
- Organization
- National Institutes of Health
Study Officials
- PRINCIPAL INVESTIGATOR
Eric M Wassermann, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 13, 2017
Study Start
March 24, 2017
Primary Completion
March 10, 2020
Study Completion
August 7, 2020
Last Updated
April 12, 2021
Results First Posted
April 12, 2021
Record last verified: 2020-06