Functional Connectivity as a Biomarker of rTMS
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/5/2019 |
| Start Date: | March 24, 2017 |
| End Date: | February 1, 2020 |
| Contact: | Jack A Reeves |
| Email: | jack.reeves@nih.gov |
| Phone: | (301) 496-0220 |
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.
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.
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 and to pilot one such paradigm for improving memory in traumatic
brain injury (TBI) patients. Ancillary outcomes include the effects of rTMS on the explicit
and implicit memory systems and the potential effects of manipulating one system on the
other.
Study population: Healthy adult volunteers and patients with TBI
Design: The study contains 3 experiments. Experiment 1 is designed to establish the number of
rTMS sessions required to produce a meaningful change in resting parietohippocampal FC in
healthy subjects. Experiment 2 will apply this information to an experiment aimed at
enhancing fronto-striatal FC and, as a secondary outcome, enhancing implicit memory. This
intervention will be contrasted with parietal stimulation and a negative control condition
(vertex stimulation) in a between-groups design. In Experiment 3, we will adapt a paradigm
used by others in healthy subjects to amnestic TBI patients in an effort to enhance
parieto-hippocampal FC and, as a secondary outcome, explicit memory. This will be compared to
negative control (vertex) stimulation in a within-subjects design
Outcome measures: The primary outcome measure is the change in FC produced by serially
applied rTMS. Secondary measures will be changes in explicit and implicit memory performance.
We will explore whether white matter integrity predicts changes in FC in healthy subjects and
patients.
modulation by repetitive transcranial magnetic stimulation (rTMS) in paradigms intended to
improve memory and learning and to pilot one such paradigm for improving memory in traumatic
brain injury (TBI) patients. Ancillary outcomes include the effects of rTMS on the explicit
and implicit memory systems and the potential effects of manipulating one system on the
other.
Study population: Healthy adult volunteers and patients with TBI
Design: The study contains 3 experiments. Experiment 1 is designed to establish the number of
rTMS sessions required to produce a meaningful change in resting parietohippocampal FC in
healthy subjects. Experiment 2 will apply this information to an experiment aimed at
enhancing fronto-striatal FC and, as a secondary outcome, enhancing implicit memory. This
intervention will be contrasted with parietal stimulation and a negative control condition
(vertex stimulation) in a between-groups design. In Experiment 3, we will adapt a paradigm
used by others in healthy subjects to amnestic TBI patients in an effort to enhance
parieto-hippocampal FC and, as a secondary outcome, explicit memory. This will be compared to
negative control (vertex) stimulation in a within-subjects design
Outcome measures: The primary outcome measure is the change in FC produced by serially
applied rTMS. Secondary measures will be changes in explicit and implicit memory performance.
We will explore whether white matter integrity predicts changes in FC in healthy subjects and
patients.
- 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:
Healthy subjects
- 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
TBI Patients
- Any current major neurological or psychiatric disorder unrelated to TBI, such as (but
not limited to) stroke, Parkinson disease, Alzheimer disease, schizophrenia or major
depression.
- History of seizure
- Inability to give informed consent
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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