Imaging the Effects of rTMS on Chronic Pain



Status:Not yet recruiting
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:21 - 60
Updated:4/21/2016
Start Date:March 2016
End Date:December 2020
Contact:Diana Martinez, MD
Email:dm437@cumc.columbia.edu
Phone:646-774-6160

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Neuropathic pain is difficult to treat and is associated with the development of mood and
substance use disorders. Most medications are only moderately effective, and deep brain
stimulation is being used to treat sever chronic neuropathic pain. However, this requires
brain surgery. The goal is to investigate the use of transcranial magnetic stimulation (TMS)
directed at the medial prefrontal cortex and anterior cingulate for this disorder. These
brain regions are in the prefrontal cortex, and research from deep brain stimulation studies
indicated that stimulating this region may help treat pain. This is a pilot study to
investigate the use of transcranial magnetic stimulation (TMS) directed at the regions in
the prefrontal cortex using the H7 coil, which was developed to reach these deeper brain
structures. While previous studies have investigated rTMS for pain, none, have used this
coil to target these brain regions. This study will investigate active vs sham treatment in
chronic pain participants.

Neuropathic pain is estimated to affect 3%--‐4.5% of the worldwide population and is
associated with significant loss of productivity and the development of mood and substance
use development of mood and substance use disorders. Chronic neuropathic pain is difficult
to treat with medication and deep brain stimulation (DBS) targeting subcortical structures
(periaqueductal gray or thalamic nuclei) has been investigated for refractory neuropathic
pain. However, recent work indicates that stimulation of the dorsal anterior cingulate
cortex (dACC) may be a new potential neuromodulatory target, given its role in affective
processing of pain.

In this pilot study, the investigator proposes to investigate the use of repetitive
transcranial magnetic stimulation (rTMS) directed at the medial prefrontal cortex and
anterior cingulate as a potential treatment for neuropathic pain. Previous studies using
rTMS for pain have shown some indicators of success, and this study will investigate the
effect of the H7 coil, which reaches the medial prefrontal cortex and the anterior
cingulate, on chronic pain syndromes. Using the H7 coil, which was developed to reach deeper
structures in the prefrontal cortex including the anterior cingulate, this study will
investigate active vs sham treatment in chronic pain participants.

Inclusion Criteria:

1. Chronic neuropathic pain

2. Age 21-60

3. Able to give informed consent, and comply with study procedures

Exclusion Criteria:

1. Medically conditions that preclude rTMS, including glaucoma, increased intracranial
pressure, cardiac disease, migraine disorder, cerebral vascular events (CVA, TIA) any
brain lesions (such multiple sclerosis), or seizure disorders.

2. Meet DSM-V criteria for major psychiatric illness, such as bipolar disorder, major
depression (severe), or psychosis, that would interfere with participation or pose a
risk for rTMS.

3. Cognitive Disorder

4. Currently pregnant

5. Metal implants or paramagnetic objects contained within the body which may interfere
with the MRI scan, as determined in consultation with a neuroradiologist and
according to the guidelines set forth in the following reference book commonly used
by neuroradiologists: "Guide to MR procedures and metallic objects" Shellock, PhD,
Lippincott-Raven press, NY 1998.14. This includes metal or shrapnel or bullet in the
head or body, including metal shavings.

6. Participants with positive responses to the Transcranial Magnetic stimulation Adult
safety screen (TASS)

7. Currently taking a medication known to increase the risk of seizure.

8. Participants with claustrophobia making them unable to tolerate scanning.

9. Participants in need of urgent surgery for their pain condition

10. Participants involved in litigation regarding injury or workers compensation
benefits.

11. Participants with a diagnosis of vasculitis, peripheral vascular disease, peripheral
neuropathy, small-fiber neuropathy, or fibromyalgia.
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
646-774-5000
Phone: 646-774-6160
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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New York, NY
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