Trial Summary
What is the purpose of this trial?This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.
Is the treatment rTMS a promising treatment for headaches related to mild traumatic brain injury?Yes, rTMS is a promising treatment for headaches related to mild traumatic brain injury. Studies show that it can help reduce these headaches and improve related symptoms by using magnetic pulses to stimulate specific areas of the brain.45678
Do I have to stop taking my current medications for this 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.
What safety data is available for rTMS in treating headaches?Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe, with common side effects including headache, stimulation pain, and discomfort, which typically improve with continued treatment. The most severe side effect is the induction of seizures, occurring at a rate of less than 0.1%. It is important to monitor for medications that affect seizure thresholds and the presence of metal in the body. rTMS is FDA approved for depression and has been studied for chronic pain management, including headaches related to mild traumatic brain injury.13456
What data supports the idea that rTMS and Headache Management for mTBI-Related Headaches is an effective treatment?The available research shows that repetitive transcranial magnetic stimulation (rTMS) can help reduce headaches related to mild traumatic brain injury (mTBI). Studies have found that rTMS can alleviate headaches and improve related symptoms like depression and cognitive issues. For example, one study reported that participants experienced a significant reduction in post-concussion symptoms, including headaches, after receiving rTMS. Another study showed that real rTMS treatment led to better brain function compared to a fake treatment. These findings suggest that rTMS is a promising option for managing headaches in people with mTBI.24568
Eligibility Criteria
This trial is for adults aged 18-65 who have had a mild traumatic brain injury (mTBI) and suffer from persistent headaches that started after their injury. They must not have received TMS treatment before, and their headache intensity should be over 30 on a scale of 100. People with metal implants, seizure history, major psychiatric diseases, or chronic pain conditions other than mTBI-related headaches cannot participate.Inclusion Criteria
I did not have daily headaches before my mild brain injury.
I experience severe headaches rated over 30 on a scale of 100.
I am between 18 and 65 years old.
I have had chronic headaches for more than 3 months after an injury.
I have never received TMS treatment.
Exclusion Criteria
I cannot understand English.
I have had seizures in the past.
I have long-term nerve pain conditions.
Treatment Details
The study tests if active repetitive transcranial magnetic stimulation (rTMS), combined with telehealth therapy, can reduce headaches caused by mild traumatic brain injuries better than placebo treatments. Participants will either receive the real rTMS treatment along with headache management therapy or sham rTMS with basic headache education.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Sham rTMS with telehealth headache management therapyExperimental Treatment2 Interventions
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Group II: Active rTMS with telehealth headache education controlExperimental Treatment2 Interventions
Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Group III: Active rTMS with telehealth headache management therapyActive Control2 Interventions
Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Group IV: Sham rTMS with telehealth headache education controlPlacebo Group2 Interventions
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Active rTMS is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Smoking Cessation
- Chronic Pain Syndrome
🇪🇺 Approved in European Union as rTMS for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Chronic Pain Syndrome
- Generalized Anxiety Disorder (GAD)
- Bipolar Disorder
Find a clinic near you
Research locations nearbySelect from list below to view details:
VA San Diego Healthcare SystemSan Diego, CA
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Who is running the clinical trial?
Veterans Medical Research FoundationLead Sponsor
References
Transcranial magnetic stimulation for migraine: a safety review. [2010]To review potential and theoretical safety concerns of transcranial magnetic stimulation (TMS), as obtained from studies of single-pulse (sTMS) and repetitive TMS (rTMS) and to discuss safety concerns associated with sTMS in the context of its use as a migraine treatment.
Noninvasive brain stimulation for persistent postconcussion symptoms in mild traumatic brain injury. [2022]Mild traumatic brain injury (mTBI) is typically followed by various postconcussive symptoms (PCS), including headache, depression, and cognitive deficits. In 15-25% of cases, PCS persists beyond the usual 3-month recovery period, interfering with activities of daily living and responding poorly to pharmacotherapy. We tested the safety, tolerability, and efficacy of repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) for alleviating PCS. Fifteen eligible patients with mTBI and PCS > 3 months postinjury consented to 20 sessions of rTMS (20 × 5-sec trains; 10 Hz at 110% threshold), with clinical and functional magnetic resonance imaging (fMRI) assessments before and after intervention and clinical assessment at 3-month follow-up. Primary outcomes were tolerability, safety, and efficacy, as measured with the PCS Scale. Secondary outcomes included the Cognitive Symptoms Questionnaire, neuropsychological test performance, and working memory task-associated activity as assessed with fMRI. Twelve patients completed all sessions. Three withdrew because of worsening symptoms or for an unrelated event. Stimulation intensity was increased gradually across sessions, and all subjects tolerated the protocol by the sixth session. Commonly reported side effects among completers were increased headache (n = 3) and greater sleep disturbance (n = 3). Participants also reported positive outcomes such as less sleep disturbance (n = 3), and better mental focus (n = 3). On average, PCS scores declined by 14.6 points (p = 0.009) and fMRI task-related activation peaks in the DLPFC increased after rTMS. rTMS is safe, tolerated by most patients with mTBI, and associated with both a reduction in severity of PCS and an increase in task-related activations in DLPFC. Assessment of this intervention in a randomized, control trial is warranted.
[Clinical Application and Safety of rTMS in Japan and Overseas]. [2015]Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive technique that can stimulate the cerebral cortex and alter cortical and subcortical activities, and it has been approved to treat depression in the USA, Australia, and Europe. In Japan, several manufacturers have focused on obtaining approval for rTMS. In terms of the safety and tolerability of rTMS, headache, stimulation pain, and discomfort occur at relatively high frequencies during rTMS, but these events usually improve rapidly as the number of treatment days increases. The induction of seizures is the most severe side effect of rTMS, and its rate is less than approximately 0.1%. In the practice of rTMS, it is critically important to check for medications known to modify the seizure threshold and any metal in the body, and to assess the risk of seizures.
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).
rTMS in Alleviating Mild TBI Related Headaches--A Case Series. [2018]Headache is one of the most common debilitating chronic pain conditions in patients with mild traumatic brain injury. Conventional pharmacological treatments have not been shown to be effective in alleviating debilitating mild traumatic brain injury related headaches (MTBI-HA). Therefore, the development of an innovative non-invasive therapy in managing MTBI-HA is needed in the field of pain management. Repetitive transcranial magnetic stimulation (rTMS) utilizes a basic electromagnetic coupling principle in which a rapid discharge of electrical current is converted into dynamic magnetic flux, allowing the induction of a localized current in the brain for neuromodulation. The treatment is currently FDA approved for treating depression in the United States. Recent meta-analysis studies have implicated its usage in chronic pain management.
Left Dorsolateral Prefrontal Cortex rTMS in Alleviating MTBI Related Headaches and Depressive Symptoms. [2022]Persistent mild traumatic brain injury related headache (MTBI-HA) represents a neuropathic pain state. This study tested the hypothesis that repetitive transcranial magnetic stimulation (rTMS) at the left prefrontal cortex can alleviate MTBI-HA and associated neuropsychological dysfunctions.
Repetitive transcranial magnetic stimulation in chronic tension-type headache: A pilot study. [2020]Tension-type headache (TTH) is the most common type of primary headache disorder. Its chronic form is often the most ignored and challenging to treat. Transcranial magnetic stimulation (TMS) is a novel technique in the treatment of chronic pain. The aim of this pilot study was to explore the effect of low-frequency repetitive TMS (rTMS) on pain status in chronic TTH (CTTH) by subjective and objective pain assessment.
fMRI findings in MTBI patients with headaches following rTMS. [2022]Mild Traumatic Brain Injury (MTBI) patients with persistent headaches are known to have diminished supraspinal modulatory connectivity from their prefrontal cortices. Repetitive transcranial magnetic stimulation (rTMS) is able to alleviate MTBI-related headache (MTBI-HA). This functional magnetic resonance imaging (fMRI) study assessed supraspinal correlates associated with the headache analgesic effect of rTMS at left prefrontal cortex (LPFC), hypothesizing real rTMS would significantly increase modulatory functions at LPFC in comparison to sham treatment. Subjects with MTBI-HA were randomized to receive either real or sham rTMS treatments and subjected to pre- and post-treatment resting state and evoked heat-pain fMRI as described in a prior study. Real rTMS consisted of 2000 pulses delivered at 10 Hz and 80% of the resting motor threshold at left dorsolateral prefrontal cortex, whereas sham treatment was delivered with same figure-of-eight coil turned 180 degrees. Follow-up fMRI was performed one-week post-treatment. All fMRI data was processed using BrainVoyager QX Software. 14 subjects receiving real and 12 subjects receiving sham treatments completed the study. The REAL group demonstrated significant (P