- On October 17, 2017
WHAT IS REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION & CAN IT IMPROVE NEUROLOGICAL FUNCTION FOLLOWING TRAUMATIC BRAIN INJURY?
Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy that involves using a magnet to target and stimulate certain areas of the brain.
In rTMS, a magnet is placed outside the head to target specific parts of the brain for activation. It was first used in 1985 as a treatment for depression, psychosis, anxiety, and other disorders in lieu of generalized electroshock (electroconvulsive) therapy. In 2008, it was FDA approved to treat intractable major depression. rTMS is now being explored to assist in recovery from brain injury.
rTMS treatment sessions typically last 30-60 minutes, and treatment is painless. Electromagnetic pulses are administered via an electromagnetic coil held against the head near the area of the brain being targeted for stimulation. The electromagnetic pulses trigger small electrical currents in the brain, stimulating nerve cells in the desired area. The pulse typically reaches about 2 inches into the brain.
Research on the use of rTMS in adults with brain injury is very promising, and additional research is ongoing.
One such study is being conducted at Santa Clara Valley Medical Center (SCVMC) in northern California. The research project discussed below is exploring the use of rTMS to improve neurological function in adults with disorders of consciousness (vegetative state1and minimally conscious state2). SCVMC is 1 of only 14 centers in the United States to be designated as a “Model System” for the treatment of traumatic brain injuries (TBI) by the National Institute of Disability Rehabilitation and Research.
The ongoing SCVMC trial is actively recruiting participants. Participation is covered by research funding and is free of charge to the patient. Here is information regarding this open study:
An Experimental Treatment to Restore Function after Severe TBI
The purpose of this study is to examine the safety and efficacy of repetitive transcranial magnetic stimulation, an experimental treatment for individuals in a vegetative or minimally conscious state. The rTMS protocol employed in the clinical trial is based on pilot data collected from 3 subjects. Despite a poor likelihood of recovery in these 3 patients, all 3 pilot participants made neurobehavioral gains during rTMS, and each maintained these gains at follow-up.
Eligibility criteria for entry into the current study include:
- adults 18 years or older with a TBI,
- a persistent state of seriously impaired consciousness (vegetative or minimally conscious), and
- 3 to 24 months since TBI.
The study is a double-blind, randomized, placebo-controlled trial, lasting 10 weeks.
- Week 1: Admission to SCVMC and assessment of Baseline Measures,
- Weeks 2-5: rTMS Intervention (30 active or placebo/sham rTMS sessions),
- Week 6: Endpoint Measurement/Discharge from SCVMC,
- Weeks 6-9: Weekly safety and neurological follow-up,
- Week 10: Re-admission to SCVMC/Final Endpoint Measurement/Discharge from SCVMC.
- At the end of 10 weeks, the surrogate/family member will learn via letter to which treatment group the research participant was assigned (placebo vs. actual treatment). The surrogate will have the opportunity to consider enrolling the research participant in the study again with the assurance of being assigned to the real rTMS treatment group.
This study hopes to improve our understanding of brain functioning and recovery after severe brain injury and how different areas of the brain contribute to awareness and recovery. The possible contribution of rTMS to improved clinical outcomes will be assessed. For further information on the study, its locations, and sponsors and collaborators, please visit: https://clinicaltrials.gov/ct2/show/NCT02366754?term=NCT02366754&rank=1.
For more information on all research projects at the Santa Clara Valley Medical Center Rehabilitation Research Center, please visit: https://www.scvmc.org/health-care-services/Rehabilitation/Rehabilitation-Research-Center/Pages/Research-Projects.aspx.
- Vegetative state is defined as a condition of unconsciousness, devoid of cognitive content. It is characterized by wakefulness (eyes open) without awareness. Vegetative state is also known as unresponsive wakefulness syndrome.
- Minimally conscious state (MCS) is a condition in which unequivocally meaningful responses are observed, albeit on an inconsistent basis. MCS is a clinical diagnosis that requires behavioral evidence of meaningful interaction, such as sustained visual pursuit, command following, reaching toward an object or other meaningful motor response, intelligible verbalization, and/or the use of gestures to communicate.MCS is sometimes misdiagnosed as vegetative state because bedside verification of meaningful responses can be difficult in patients who exhibit daily fluctuations in consciousness. Although clinical assessment with appropriate behavioral scales remains the gold standard for diagnosing disorders of consciousness, up to 35%–40% of patients are still misdiagnosed as vegetative.