Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This study aims to look at the effectiveness of using repetitive transcranial magnetic stimulation (rTMS) in relieving pain and other co-morbid symptoms of Gulf War Illness.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment rTMS for Gulf War Syndrome?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can help reduce symptoms in conditions like PTSD, depression, and chronic pain, which are similar to symptoms experienced in Gulf War Syndrome. For example, rTMS has been effective in reducing PTSD symptoms in veterans and improving depressive symptoms in military personnel.
12345Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) has been studied for safety in both healthy individuals and those with various brain conditions. While generally considered safe, it can cause side effects like seizures, especially at high intensities, and temporary hearing changes. Safety guidelines have been developed to minimize risks, and these guidelines have been updated over the years to ensure safe use.
678910How is the treatment rTMS unique for Gulf War Syndrome?
rTMS (Repetitive Transcranial Magnetic Stimulation) is unique for Gulf War Syndrome because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, which is different from traditional drug therapies. This method has been used for other conditions like depression and brain injury, offering a novel approach by directly targeting brain activity without medication.
911121314Eligibility Criteria
This trial is for Gulf War veterans under 65 who experience weekly headaches, muscle and joint pain, meet specific GWI criteria, and have a certain level of depression. It's not for those with pacemakers, metal in their body that affects MRI scans, major psychiatric conditions, other chronic pain states, history of seizures or brain injury.Inclusion Criteria
I experience severe headaches weekly that last more than an hour.
My daily joint pain in my arms or legs averages more than 3 out of 10.
My daily muscle pain is more than 3 on a scale of 0 to 10.
I am under 65 and served in the Persian Gulf War region for at least 30 days.
Exclusion Criteria
I suffer from chronic tension or cluster headaches.
I understand the study and can communicate in English.
I have low back pain due to a nerve or joint problem.
I do not have a history of dementia, major psychiatric diseases, or life-threatening diseases.
I have chronic nerve pain like CRPS or painful neuropathy.
I have had seizures in the past.
Participant Groups
The study tests if repetitive transcranial magnetic stimulation (rTMS) can reduce pain and related symptoms in Gulf War Illness. Participants will receive either real rTMS or a sham (fake) treatment to compare effectiveness.
4Treatment groups
Active Control
Placebo Group
Group I: Active rTMS at the LDLPFCActive Control1 Intervention
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left dorsolateral prefrontal cortex (LDLPFC).
Group II: Active rTMS at the LMCActive Control1 Intervention
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC)
Group III: Sham rTMS at the LDLPFCPlacebo Group1 Intervention
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LDLPFC.
Group IV: Sham rTMS at the LMCPlacebo Group1 Intervention
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC.
rTMS is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
- Migraines
- Smoking cessation
๐ช๐บ Approved in European Union as rTMS for:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
VA San Diego Healthcare System, San Diego, CASan Diego, CA
VA Palo Alto Health Care System, Palo Alto, CAPalo Alto, CA
Atlanta VA Medical and Rehab Center, Decatur, GADecatur, GA
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
Use of Repetitive Transcranial Magnetic Stimulation in the Treatment of Neuropsychiatric and Neurocognitive Symptoms Associated With Concussion in Military Populations. [2022]Since the year 2000, over 342 000 military service members have experienced a concussion, often associated with chronic neuropsychiatric and neurocognitive symptoms. Repetitive transcranial magnetic stimulation (rTMS) protocols have been developed for many of these symptoms in the general population.
Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. [2022]Headache is one of the most common debilitating chronic pain conditions in either active or retired military personnel with mild traumatic brain injury (MTBI). This study assessed the effect of repetitive transcranial magnetic stimulation (rTMS) in alleviating MTBI-related headache (MTBI-HA).
Use of repetitive transcranial magnetic stimulation in pain relief. [2022]Repetitive transcranial magnetic stimulation (rTMS) of the cerebral cortex is a noninvasive strategy that could have the potential to relieve severe chronic pain, at least partially and transiently. The most studied target of stimulation is the precentral (motor) cortex, but other targets, such as the dorsolateral prefrontal cortex or the parietal cortex, could be of interest. Analgesic effects have been produced by rTMS in patients with neuropathic pain, fibromyalgia or visceral pain. Therapeutic applications of rTMS in pain syndromes are limited by the short duration of the induced effects, but prolonged pain relief can be obtained by performing rTMS sessions every day for several weeks. In patients who respond to rTMS but relapse, surgical implantation of epidural cortical electrodes and a pulse generator can be proposed to make clinical effects more permanent. The rate of improvement produced by rTMS may be predictive for the outcome of the implanted procedure. The place of rTMS as a therapeutic tool in the management of chronic pain remains to be determined.
Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression in Active-Duty Service Members Improves Depressive Symptoms. [2022]Current research on the efficacy of repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex as a noninvasive therapy for treatment-resistant depression is largely settled science. However, little is known about its efficacy with active-duty service members (ADSMs) with major depressive disorder. In a retrospective chart review, we examined depressive symptom ratings in ADSMs seeking treatment at the US Army Outpatient Behavioral Health Service Clinic at Eisenhower Army Medical Center, Fort Gordon, Ga.
Repetitive transcranial magnetic stimulation and threat memory: selective reduction of combat threat memory p300 response after right frontal-lobe stimulation. [2012]Using the event-related potential P3a component as a marker, the authors tested the efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing hyperarousability to specific threat stimuli in one Vietnam veteran with chronic posttraumatic stress disorder (PTSD), who exhibited an exaggerated P3a response to combat-related pictures. Twenty minutes of 1-Hz rTMS to the right prefrontal area effected a reduction in the P3a amplitude, whereas similar rTMS to the left prefrontal area did not. In addition to providing evidence for the effectiveness of right frontal rTMS for an exaggerated response to trauma-related stimuli, this study provides electrophysiological corroboration of subjective reports of PTSD symptoms.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021]In the last decade, repetitive transcranial magnetic stimulation (rTMS) has been introduced as a non-invasive neuromodulation therapy for depression. Little is known, however, about (serious) adverse events (AE) of rTMS in older adults with a depression. In this article, we want to study what is known about (serious) AE of rTMS in older adults (>60 years) with late-life depression (LLD).
Safety of rapid-rate transcranial magnetic stimulation in normal volunteers. [2019]In 9 normal volunteers, we studied the safety of rapid-rate transcranial magnetic stimulation (rTMS) applied to different scalp positions at various frequencies and intensities. Pure tone threshold audiometry showed temporary threshold shifts in 3 subjects. In the subject stimulated at the highest intensity, rTMS induced a focal, secondarily generalized seizure despite the absence of definite risk factors for seizures. Rapid-rate TMS did not result in any important changes in the neurological examination findings, cognitive performance, electroencephalogram, electrocardiogram, and hormone levels (prolactin, adrenocorticotropic hormone, thyroid-stimulating hormone, luteinizing hormone, and follicle-stimulating hormone). In 10 additional subjects, the electromyographic activity in several contralateral muscles showed that trains of rTMS applied to the motor cortex induced a spread of cortical excitability. The spread of excitability depended on the intensity and frequency of the stimuli and probably constituted an early epileptogenic effect of rTMS. Guidelines for preventing the undesirable side effects of rTMS are offered.
Repetitive transcranial magnetic stimulation-associated neurobehavioral gains during coma recovery. [2016]Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method to induce changes in cortical neural excitability. This report presents findings from the first participant of a safety and efficacy study that examined a therapeutic rTMS protocol for persons with severe traumatic brain injury (TBI).
Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022]Single-pulse transcranial magnetic stimulation (TMS) is a safe and useful tool for investigating various aspects of human neurophysiology, particularly corticospinal function, in health and disease. Repetitive TMS (rTMS), however, is a more powerful and potentially dangerous modality, capable of regionally blocking or facilitating cortical processes. Although there is evidence that rTMS is useful for treating clinical depression, and possibly other brain disorders, it had caused 7 known seizures by 1996 and could have other undesirable effects. In June 1996 a workshop was organized to review the available data on the safety of rTMS and to develop guidelines for its safe use. This article summarizes the workshop's deliberations. In addition to issues of risk and safety, it also addresses the principles and applications of rTMS, nomenclature, and potential therapeutic effects of rTMS. The guidelines for the use of rTMS, which are summarized in an appendix, cover the ethical issues, recommended limits on stimulation parameters, monitoring of subjects (both physiologically and neuropsychologically), expertise and function of the rTMS team, medical and psychosocial management of induced seizures, and contra-indications to rTMS.
Accelerated transcranial magnetic stimulation (aTMS) to treat depression with treatment switching: study protocol of a pilot, randomized, delayed-start trial. [2021]Repetitive transcranial magnetic stimulation (rTMS) is a technique for stimulating brain activity using a transient magnetic field to induce an electrical current in the brain producing depolarization of focal groups of brain cells. TMS is a protocol approved by the U.S. Food and Drug Administration in routine clinical practice as a treatment for depression. A major limitation of rTMS is the large amount of time taken for a standard protocol (38 min a day for 20-30 working days). The optimal type and duration of TMS are still uncertain, as is the optimal strategy for continuing or changing the type of rTMS if there is a poor initial response.
A naturalistic, multi-site study of repetitive transcranial magnetic stimulation therapy for depression. [2019]Repetitive transcranial magnetic stimulation (rTMS) was approved in 2008 in the United States, and there are relatively few studies describing its use in regular clinical practice since approval.
Low-frequency rTMS in patients with subacute ischemic stroke: clinical evaluation of short and long-term outcomes and neurophysiological assessment of cortical excitability. [2018]Repetitive transcranial magnetic stimulation (rTMS) is used alone or in combination with physiotherapy for rehabilitation of stroke patients. TMS mapping can also quantify the excitability of the motor area in both the ipsilesional (IL) and contralateral (CL) hemisphere.
[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]Repetitive magnetic stimulation (rTMS) is a non-invasive, painless method to induce transient activation in circumscript regions of the human cortex. In contrast to TMS with single pulses rTMS allows a more effective stimulation of association cortex and temporary interference with the proper functioning of stimulated areas. Possible applications for examination of the functional anatomy of language lateralisation, memory functions and visual perception are discussed. Possible therapeutic for movement disorders and depression are discussed. On the basis of theoretical considerations and current experience rTMS induced epileptogenic effects are discussed and safety recommendations are given.