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Functional Connectivity as a Biomarker of rTMS

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ClinicalTrials.gov Identifier: NCT03050801
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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.

At the visits, participants will have all or some of the following:

  • MRI for about 1 hour. They will lie in a machine that takes pictures in a magnetic field. They 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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: rTMS Phase 1 Phase 2

Detailed Description:

Objective: To use resting state functional connectivity (FC) as a biomarker of synaptic modulation by repetitive transcranial magnetic stimulation (rTMS) in paradigms intended to improve memory and learning. Ancillary outcomes include the effects of rTMS on the interaction between the explicit implicit memory systems.

Study population: Healthy adult volunteers

Design: The study contains two experiments. Experiment 1 is designed to establish the number of rTMS sessions required to produce a meaningful change in resting parieto-hippocampal FC in healthy subjects. Experiment 2 will replicate a prior experiment which used rTMS to enhance the explicit memory system in healthy subjects, and look for potential effects on the implicit system. This intervention will be contrasted with a negative control condition (vertex stimulation) in a between-groups design.

Outcome measures: The primary outcome measure is the change in FC produced by

serially applied rTMS and improvement in explicit memory. We will explore whether enhancement of the explicit system has effects on resting state connectivity in the implicit system and whether white matter integrity predicts changes in FC in healthy subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Connectivity as a Biomarker of rTMS
Actual Study Start Date : March 24, 2017
Actual Primary Completion Date : March 10, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Frontal rTMS-Active
Prefrontal rTMS
Device: rTMS
Altering the connectivity of trans-synaptic pathways

Experimental: Frontal rTMS-Experimental
Prefrontal rTMS
Device: rTMS
Altering the connectivity of trans-synaptic pathways

Active Comparator: Parietal rTMS-Active
Prefrontal rTMS
Device: rTMS
Altering the connectivity of trans-synaptic pathways

Active Comparator: Parietal rTMS-Active 2
Parietal rTMS
Device: rTMS
Altering the connectivity of trans-synaptic pathways

Experimental: Parietal rTMS-Experimental
Parietal rTMS
Device: rTMS
Altering the connectivity of trans-synaptic pathways

Active Comparator: Vertex rTMS-Active
Vertex rTMS
Device: rTMS
Altering the connectivity of trans-synaptic pathways

Placebo Comparator: Vertex rTMS-Placebo
Vertex rTMS
Device: rTMS
Altering the connectivity of trans-synaptic pathways




Primary Outcome Measures :
  1. Functional connectivity [ Time Frame: First day of stimulation, Prior to Stimulation, 18-36 hours after last stimulation, 7-10 days after final rTMS ]
    to determine whether functional connectivity can be used as a biomarker of rTMS synaptic modulation


Secondary Outcome Measures :
  1. Memory tests [ Time Frame: 1hr, 1wk ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Healthy individuals in Experiments 1 and 2.

Age 18-50 (inclusive)

- English speaking and writing

Patients in 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.

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050801


Contacts
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Contact: Cynthia M Fioriti (301) 402-6921 cynthia.fioriti@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Eric M Wassermann, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03050801    
Other Study ID Numbers: 170055
17-N-0055
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 23, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Explicit Memory
Implicit Memory
Memory Disorder
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries