Trial Summary
What is the purpose of this trial?The proposed studies focus on memory for speech movements and sounds and its relation to learning. Continuous theta-burst transcranial magnetic stimulation (cTBS) will be used to suppress activity in a region of pre-frontal cortex associated with somatic and auditory working memory (Brodmann area 46v) to test its involvement in learning.
How is the treatment cTBS different from other treatments for speech motor learning?
Continuous theta-burst stimulation (cTBS) is unique because it uses magnetic pulses to temporarily reduce brain activity in specific areas, which can help with learning speech motor skills by targeting the brain's motor cortex. Unlike other treatments, cTBS can produce longer-lasting effects with a brief session, making it a novel approach for enhancing speech motor learning.
35789Is theta-burst transcranial magnetic stimulation (TBS) safe for humans?
Theta-burst transcranial magnetic stimulation (TBS) is generally considered safe for humans, with most adverse events being mild and occurring in about 5% of people. However, there is a small risk of seizures, so it should be used with caution, especially since it is a relatively new technique.
12347What data supports the effectiveness of the treatment Adaptation, cTBS, Continuous Theta-Burst Stimulation, cTBS, Theta-Burst Transcranial Magnetic Stimulation for speech motor learning?
Research shows that continuous theta burst stimulation (cTBS) can influence brain activity related to motor learning, which might help in speech motor learning. Studies have found that cTBS can affect motor cortex excitability and motor learning, suggesting it could be useful for improving speech-related motor skills.
13569Will I have to stop taking my current medications?
Yes, you will need to stop taking antipsychotic, antidepressant, and antianxiety drugs to participate in this trial.
Eligibility Criteria
This trial is for right-handed adults with no known physical or neurological abnormalities. It's not suitable for those with metal in their body, claustrophobia, on antipsychotic/antidepressant/antianxiety drugs, pregnant women, anyone with heart clips or implants, a history of concussion or epilepsy.Inclusion Criteria
I do not have any known physical or neurological abnormalities.
Exclusion Criteria
I am currently on medication for anxiety.
I have had a concussion before.
I am currently on antidepressant medication.
I am currently on antipsychotic medication.
I have surgical clips or valves in my heart.
Participant Groups
The study tests how suppressing activity in part of the brain (Brodmann area 46v) using cTBS affects learning speech movements and sounds. The focus is on understanding memory's role in speech motor learning.
5Treatment groups
Experimental Treatment
Group I: Somatosensory Sensory MemoryExperimental Treatment1 Intervention
Somatosensory Sensory Memory
Group II: Sensory Memory + cTBS to 46vExperimental Treatment2 Interventions
Sensory Memory + cTBS to 46v
Group III: Auditory Sensory MemoryExperimental Treatment1 Intervention
Auditory Sensory Memory
Group IV: Adaptation to Altered Auditory Feedback + cTBS to 46vExperimental Treatment2 Interventions
Adaptation to Altered Auditory Feedback + cTBS to 46v
Group V: Adaptation to Altered Auditory FeedbackExperimental Treatment1 Intervention
Adaptation to Altered Auditory Feedback
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:
McGill UniveristyMontréal, Canada
McGill UniversityMontréal, Canada
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Who is running the clinical trial?
Yale UniversityLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
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
Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]Theta burst stimulation (TBS) protocols have recently emerged as a method to transiently alter cortical excitability in the human brain through repetitive transcranial magnetic stimulation. TBS involves applying short trains of stimuli at high frequency repeated at intervals of 200 milliseconds. Because repetitive transcranial magnetic stimulation is known to carry a risk of seizures, safety guidelines have been established. TBS has the theoretical potential of conferring an even higher risk of seizure than other repetitive transcranial magnetic stimulation protocols because it delivers high-frequency bursts. In light of the recent report of a seizure induced by TBS, the safety of this new protocol deserves consideration. We performed an English language literature search and reviewed all studies published from May 2004 to December 2009 in which TBS was applied. The adverse events were documented, and crude risk was calculated. The majority of adverse events attributed to TBS were mild and occurred in 5% of subjects. Based on this review, TBS seems to be a safe and efficacious technique. However, given its novelty, it should be applied with caution. Additionally, this review highlights the need for rigorous documentation of adverse events associated with TBS and intensity dosing studies to assess the seizure risk associated with various stimulation parameters (e.g., frequency, intensity, and location).
Prolonged motor skill learning--a combined behavioural training and θ burst TMS study. [2013]To assess the behavioural effects of prolonged motor practice in healthy volunteers, and the specific impact of inhibiting different motor-related brain regions in the late phase of motor learning using continuous theta burst transcranial magnetic stimulation (cTBS).
Safety and tolerability of theta-burst transcranial magnetic stimulation in children. [2012]Theta-burst stimulation (TBS) is a lower intensity, high-frequency repetitive transcranial magnetic stimulation technique developed recently for quantifying and modulating cerebral cortical function. Nearly all published studies have involved adults. The aim of this study was to obtain safety data as a basis for evaluating potential risks versus benefits of TBS research in children.
Paired associative stimulation increases motor cortex excitability more effectively than theta-burst stimulation. [2022]To examine the effects of theta burst stimulation (TBS) and paired associative stimulation (PAS) on excitability in the human motor cortex.
Comparing the after-effects of continuous theta burst stimulation and conventional 1 Hz rTMS on semantic processing. [2013]Our aim was to evaluate continuous theta burst stimulation (cTBS) as a tool to induce temporary impairment (virtual lesion) in semantic processing. Four groups with 20 subjects each were stimulated. In the three experimental groups the stimulation site was the left superior temporal cortex. Stimulation was either 1Hz repetitive transcranial magnetic stimulation (rTMS) at 100% resting motor threshold (RMT) or cTBS, with intensities of 80% or 90% active motor threshold (AMT). The TMS-control group was stimulated at the right medial prefrontal cortex with 1 Hz rTMS. After stimulation subjects accomplished a lexical decision task with a duration of about 20 min. In an additional fifth group the lexical decision task was performed without TMS. Reaction times were not influenced by cTBS applied with 80% AMT, but prolonged for about 80 ms with 90% AMT compared to the no stimulation condition. An increase of 140 ms was found after 1 Hz rTMS. The effect lasted for the whole task, but declined from the first to the second half of the experiment. The direct comparison of cTBS and 1 Hz rTMS suggests that both stimulation patterns can induce virtual lesions in the left superior temporal cortex and impair semantic processing. We suppose that cTBS could replace 1 Hz rTMS in this field since the application is faster and it is more comfortable to the subjects.
Reproducibility of the effects of theta burst stimulation on motor cortical plasticity in healthy participants. [2022]Theta-burst stimulation (TBS) is a repetitive transcranial magnetic stimulation (TMS) protocol, capable of enhancing or suppressing the amplitude of contralateral motor-evoked potentials (MEP) for several minutes after stimulation over the primary motor cortex. Continuous TBS (cTBS) produces a long-term depression (LTD)-like reduction of cortical excitability. The purpose of this study was to assess the test-retest reproducibility of the effects of cTBS and to investigate which neurophysiologic markers of cTBS-induced plasticity are most reproducible.
Discrimination of speech and non-speech sounds following theta-burst stimulation of the motor cortex. [2022]Perceiving speech engages parts of the motor system involved in speech production. The role of the motor cortex in speech perception has been demonstrated using low-frequency repetitive transcranial magnetic stimulation (rTMS) to suppress motor excitability in the lip representation and disrupt discrimination of lip-articulated speech sounds (Möttönen and Watkins, 2009). Another form of rTMS, continuous theta-burst stimulation (cTBS), can produce longer-lasting disruptive effects following a brief train of stimulation. We investigated the effects of cTBS on motor excitability and discrimination of speech and non-speech sounds. cTBS was applied for 40 s over either the hand or the lip representation of motor cortex. Motor-evoked potentials recorded from the lip and hand muscles in response to single pulses of TMS revealed no measurable change in motor excitability due to cTBS. This failure to replicate previous findings may reflect the unreliability of measurements of motor excitability related to inter-individual variability. We also measured the effects of cTBS on a listener's ability to discriminate: (1) lip-articulated speech sounds from sounds not articulated by the lips ("ba" vs. "da"); (2) two speech sounds not articulated by the lips ("ga" vs. "da"); and (3) non-speech sounds produced by the hands ("claps" vs. "clicks"). Discrimination of lip-articulated speech sounds was impaired between 20 and 35 min after cTBS over the lip motor representation. Specifically, discrimination of across-category ba-da sounds presented with an 800-ms inter-stimulus interval was reduced to chance level performance. This effect was absent for speech sounds that do not require the lips for articulation and non-speech sounds. Stimulation over the hand motor representation did not affect discrimination of speech or non-speech sounds. These findings show that stimulation of the lip motor representation disrupts discrimination of speech sounds in an articulatory feature-specific way.
Differential effects of facilitatory and inhibitory theta burst stimulation of the primary motor cortex on motor learning. [2018]To evaluate the differential effects on motor learning of two types of theta burst stimulation (TBS), the excitatory intermittent TBS (iTBS) and inhibitory continuous TBS (cTBS), if TBS is applied in an early stage of learning process.