Theta-Burst Stimulation for Language Disorders (TAFE Trial)
Palo Alto (17 mi)Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Georgia State University
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to understand how transcranial magnetic stimulation affects how quickly, easily, and accurately a person read. Transcranial magnetic stimulation is a technique that uses magnetic fields to briefly affect how well certain brain regions function. The investigators would like to better understand how long the effects of transcranial magnetic stimulation occur in the reading system and at what point the effect is strongest in this system. The main questions it aims to answer are:
1. At what point after stimulation are the greatest effects on behavior seen
2. How excitatory and inhibitory stimulation affect behavior
Researchers will compare stimulation types against a sham condition to see effects on reading and language behavior.
Participants will be asked to
* undergo reading, language, and cognitive testing
* receive an MRI
* receive TMS stimulation
* perform language, reading, and motor tasks
Is Theta-Burst Stimulation a promising treatment for language disorders?Yes, Theta-Burst Stimulation, including cTBS and iTBS, shows promise as a treatment for language disorders. Studies suggest that cTBS can improve language performance in people with post-stroke aphasia by targeting specific brain areas involved in language processing. Similarly, iTBS has been shown to potentially help with language recovery in chronic post-stroke aphasia, with participants experiencing improvements in language function.5781011
What safety data exists for theta-burst stimulation treatments?Theta-burst stimulation (TBS), including both continuous (cTBS) and intermittent (iTBS) forms, has been studied for safety and tolerability in various contexts. Studies have shown that iTBS is FDA-cleared for major depressive disorder and has been assessed for safety and tolerability, with some participants experiencing tolerability issues. cTBS has also been evaluated for safety and tolerability in major depression, with studies indicating it is generally safe. Overall, TBS protocols have been shown to be safe, but individual tolerability can vary.13569
What data supports the idea that Theta-Burst Stimulation for Language Disorders is an effective treatment?The available research shows that Theta-Burst Stimulation, specifically intermittent theta burst stimulation (iTBS), can be effective for improving language abilities in people with post-stroke aphasia. In one study, participants who received iTBS showed improvements in language function compared to those who received a placebo treatment. Another study found that iTBS led to changes in brain activity that were associated with better language fluency. These studies suggest that iTBS can help the brain reorganize and improve language skills after a stroke. While the research is promising, more studies are needed to fully understand its effectiveness compared to other treatments.245810
Do I have to stop taking my current medications for the trial?The trial information does not specify whether you need to stop taking your current medications. However, certain neurological conditions like uncontrolled seizure disorders are exclusion criteria, which might imply some medication considerations. Please consult with the trial coordinators for specific guidance.
Eligibility Criteria
This trial is for individuals with reading and language disorders, as well as healthy control subjects. Participants must be willing to undergo cognitive testing, MRI scans, TMS stimulation, and perform various tasks related to language, reading, and motor skills.Treatment Details
The study investigates the timing and effects of different types of transcranial magnetic stimulation (iTBS - excitatory; cTBS - inhibitory; Sham Stimulation) on reading speed, ease, accuracy, and overall language behavior.
2Treatment groups
Experimental Treatment
Group I: iTBS/ShamExperimental Treatment2 Interventions
Adults age 18-30 with typical reading and language abilities
Group II: cTBS/ShamExperimental Treatment2 Interventions
Adults age 18-30 with typical reading and language abilities
cTBS is already approved in United States for the following indications:
🇺🇸 Approved in United States as cTBS for:
- Major Depressive Disorder (using iTBS protocol)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Georgia State UniversityAtlanta, GA
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Who is running the clinical trial?
Georgia State UniversityLead Sponsor
References
Neurochemical effects of theta burst stimulation as assessed by magnetic resonance spectroscopy. [2022]Continuous theta burst stimulation (cTBS) is a novel transcranial stimulation technique that causes significant inhibition of synaptic transmission for
Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. [2016]To identify the effective predictors for therapeutic outcomes based on intermittent theta-burst stimulation (iTBS).
Preliminary assessment of the therapeutic efficacy of continuous theta-burst magnetic stimulation (cTBS) in major depression: a double-blind sham-controlled study. [2018]Theta-burst transcranial magnetic stimulation (TBS) has been shown to induce potent and long lasting effects on cortical excitability. In a previous open study, we demonstrated safety, tolerability and antidepressant properties of continuous TBS (cTBS) in major depression (MD). The present study was aimed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind, sham-controlled design.
Interhemispheric Plasticity following Intermittent Theta Burst Stimulation in Chronic Poststroke Aphasia. [2018]The effects of noninvasive neurostimulation on brain structure and function in chronic poststroke aphasia are poorly understood. We investigated the effects of intermittent theta burst stimulation (iTBS) applied to residual language-responsive cortex in chronic patients using functional and anatomical MRI data acquired before and after iTBS. Lateralization index (LI) analyses, along with comparisons of inferior frontal gyrus (IFG) activation and connectivity during covert verb generation, were used to assess changes in cortical language function. Voxel-based morphometry (VBM) was used to assess effects on regional grey matter (GM). LI analyses revealed a leftward shift in IFG activity after treatment. While left IFG activation increased, right IFG activation decreased. Changes in right to left IFG connectivity during covert verb generation also decreased after iTBS. Behavioral correlations revealed a negative relationship between changes in right IFG activation and improvements in fluency. While anatomical analyses did not reveal statistically significant changes in grey matter volume, the fMRI results provide evidence for changes in right and left IFG function after iTBS. The negative relationship between post-iTBS changes in right IFG activity during covert verb generation and improvements in fluency suggests that iTBS applied to residual left-hemispheric language areas may reduce contralateral responses related to language production and facilitate recruitment of residual language areas after stroke.
Effects of Intermittent Theta Burst Stimulation on Manual Dexterity and Motor Imagery in Patients with Multiple Sclerosis: A Quasi-Experimental Controlled Study. [2020]Intermittent theta burst stimulation (iTBS) is a repetitive transcranial magnetic stimulation (rTMS) protocol that influences cortical excitability and motor function recovery.
Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. [2022]Treatment-resistant major depressive disorder is common; repetitive transcranial magnetic stimulation (rTMS) by use of high-frequency (10 Hz) left-side dorsolateral prefrontal cortex stimulation is an evidence-based treatment for this disorder. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered in 3 min, versus 37·5 min for a standard 10 Hz treatment session. We aimed to establish the clinical effectiveness, safety, and tolerability of iTBS compared with standard 10 Hz rTMS in adults with treatment-resistant depression.
The effect of theta-burst stimulation on unilateral spatial neglect following stroke: a systematic review. [2019]To evaluate the effectiveness of theta-burst stimulation for the treatment of stroke-induced unilateral spatial neglect.
Intermittent Theta Burst Stimulation (iTBS) for Treatment of Chronic Post-Stroke Aphasia: Results of a Pilot Randomized, Double-Blind, Sham-Controlled Trial. [2021]BACKGROUND Research indicates intermittent theta burst stimulation (iTBS) is a potential treatment of post-stroke aphasia. MATERIAL AND METHODS In this double-blind, sham-controlled trial (NCT01512264) participants were randomized to receive 3 weeks of sham (G₀), 1 week of iTBS/2 weeks of sham (G₁), 2 weeks of iTBS/1 week of sham (G₂), or 3 weeks of iTBS (G₃). FMRI localized residual language function in the left hemisphere; iTBS was applied to the maximum fMRI activation in the residual language cortex in the left frontal lobe. FMRI and aphasia testing were conducted pre-treatment, at ≤1 week after completing treatment, and at 3 months follow-up. RESULTS 27/36 participants completed the trial. We compared G0 to each of the individual treatment group and to all iTBS treatment groups combined (G₁₋₃). In individual groups, participants gained (of moderate or large effect sizes; some significant at P
Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]Intermittent theta burst stimulation (iTBS) using 600 pulses is an effective and FDA-cleared transcranial magnetic stimulation (TMS) protocol for major depressive disorder (MDD). Prolonged iTBS (piTBS) using 1,800 pulses could increase the effectiveness of TMS for MDD, but its real-world effectiveness is still debated. We assessed the safety, tolerability, and preliminary effectiveness of a 3x daily piTBS 1,800 pulses protocol delivered over 2 weeks in 27 participants. Only four participants (18.2%) achieved response, two of them achieving remission (9.1%). Five participants (18.5%) experienced tolerability issues. Future studies should focus on the neurophysiological effects of TBS protocols to determine optimal parameters.
Continuous theta burst stimulation-induced suppression of the right fronto-thalamic-cerebellar circuit accompanies improvement in language performance in poststroke aphasia: A resting-state fMRI study. [2023]Continuous theta burst stimulation (cTBS) is a specific paradigm of repetitive transcranial magnetic stimulation (rTMS) with an inhibitory effect on cortical excitability for up to 60 min after less than 1 min of stimulation. The right posterior superior temporal gyrus (pSTG), homotopic to Wernicke's area in the left hemisphere, may be a potential stimulation target based on its critical role in semantic processing. The objective of this study was to explore whether cTBS over the right pSTG can promote language improvements in aphasic patients and the underlying mechanism.
Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. [2023]As a novel type of theta burst stimulation (TBS), continuous TBS (cTBS) has been shown to have mixed therapeutic effects for major depressive disorder (MDD) or bipolar depression (BD). Thus, we performed a meta-analysis of randomized controlled trials (RCTs) of cTBS for treating major depressive episodes in patients with MDD or BD.