160 Participants Needed

Brain Stimulation for Speech Learning

DO
Overseen ByDavid Ostry
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well. The strategy for the proposed research is to identify individual brain areas that contribute causally to retention by disrupting their activity with transcranial magnetic stimulation (TMS). Investigators will also use functional magnetic resonance imaging (fMRI) which will enable identification of circuit-level activity which predicts either learning or retention of new movements, and hence test the specific contributions of candidate sensory and motor zones. In other studies, investigators will record sensory and motor evoked potentials over the course of learning to determine the temporal order in which individual sensory and cortical motor regions contribute. The goal here is to identify brain areas in which learning-related plasticity occurs first and which among these areas predict subsequent learning.

Will I have to stop taking my current medications?

The trial excludes participants who are taking psychoactive medications, so you would need to stop taking those to participate. For other medications, the protocol does not specify.

Is theta burst stimulation (TBS) safe for humans?

Theta burst stimulation (TBS), including continuous theta-burst stimulation (cTBS), is generally considered safe for humans, with most adverse events being mild and occurring in about 5% of subjects. However, there is a theoretical risk of seizures, so it should be used with caution, and more studies are needed to fully understand the safety, especially regarding seizure risk.12345

How is the treatment continuous theta-burst stimulation (cTBS) unique for speech learning?

Continuous theta-burst stimulation (cTBS) is unique because it uses a non-invasive technique called transcranial magnetic stimulation (TMS) to temporarily alter brain activity, potentially enhancing or suppressing certain brain functions. Unlike other treatments, cTBS can create 'virtual lesions' in specific brain areas, which may help researchers understand and improve speech learning by observing changes in brain activity and performance.12678

What data supports the effectiveness of the treatment Adaptation, continuous theta-burst stimulation (cTBS), continuous theta-burst stimulation, cTBS for speech learning?

Research shows that continuous theta burst stimulation (cTBS) can improve language performance in people with post-stroke aphasia, a condition affecting speech. This suggests that cTBS might help with speech learning by targeting specific brain areas involved in language processing.126910

Research Team

DO

David Ostry

Principal Investigator

Yale University

Eligibility Criteria

This trial is for right-handed, fluent English speakers with normal hearing and no speech disorders or reading disabilities. It's not suitable for individuals with a cardiac pacemaker, cochlear implant, tinnitus, metal implants in the brain or body, history of epilepsy or severe head injuries, those who are pregnant or on psychoactive medications.

Inclusion Criteria

Right-handed
No speech disorder or reading disability
I have normal hearing.

Exclusion Criteria

Cardiac pacemaker
I have a cochlear implant or experience ringing in my ears.
Aneurysm clip
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants perform learning tasks with altered or unaltered auditory feedback, followed by cTBS to specific brain regions. This is repeated on day 2.

2 days
2 visits (in-person)

Retention Assessment

Participants return 24 hours after treatment to assess retention of learning.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

  • Adaptation
  • continuous theta-burst stimulation (cTBS)
Trial Overview The study tests how learning and retaining new ways to speak might change the brain. Participants will undergo continuous theta-burst stimulation (cTBS) to disrupt brain activity and adaptation exercises while their brain function is monitored using fMRI scans and sensory/motor evoked potentials.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Unaltered auditory feedback + cTBS to somatosensory cortexExperimental Treatment2 Interventions
Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere somatosensory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
Group II: Unaltered auditory feedback + cTBS to motor cortex control zoneExperimental Treatment2 Interventions
Participants in a control condition will undergo the same procedures using cTBS to a motor cortex control zone in the right hemisphere (associated with the hand muscle first dorsal interosseous). cTBS will be applied following learning and subjects will return 24 hours later to test for retention. This control condition is included as a test for non-specific effects of cTBS stimulation. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
Group III: Unaltered auditory feedback + cTBS to motor cortexExperimental Treatment2 Interventions
Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere motor cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
Group IV: Unaltered auditory feedback + cTBS to auditory cortexExperimental Treatment2 Interventions
Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere auditory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
Group V: Altered auditory feedback + cTBS to somatosensory cortexExperimental Treatment2 Interventions
Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere somatosensory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning.
Group VI: Altered auditory feedback + cTBS to motor cortex control zoneExperimental Treatment2 Interventions
Participants in a control condition will undergo the same procedures using cTBS to a motor cortex control zone in the right hemisphere (associated with the hand muscle first dorsal interosseous). cTBS will be applied following learning and subjects will return 24 hours later to test for retention. This control condition is included as a test for non-specific effects of cTBS stimulation.
Group VII: Altered auditory feedback + cTBS to motor cortexExperimental Treatment2 Interventions
Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere motor cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning.
Group VIII: Altered auditory feedback + cTBS to auditory cortexExperimental Treatment2 Interventions
Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere auditory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Findings from Research

Continuous theta burst stimulation (cTBS) effectively inhibits synaptic transmission in the primary motor cortex for up to 1 hour, demonstrating its potential as a novel neuromodulation technique.
cTBS applied to the left motor cortex increases local GABA levels, indicating enhanced GABAergic activity, while not significantly affecting glutamate/glutamine levels, suggesting a specific mechanism of action for this stimulation technique.
Neurochemical effects of theta burst stimulation as assessed by magnetic resonance spectroscopy.Stagg, CJ., Wylezinska, M., Matthews, PM., et al.[2022]
The study found that continuous theta-burst stimulation (cTBS) can effectively reduce cortical excitability, but its effects show limited reproducibility across sessions, indicating variability in its impact.
Among the neurophysiological markers assessed, the modulation of corticospinal excitability measured 5 minutes after cTBS was the most consistent, suggesting it could be a reliable measure for future research on cTBS effects.
Reproducibility of the effects of theta burst stimulation on motor cortical plasticity in healthy participants.Vernet, M., Bashir, S., Yoo, WK., et al.[2022]
In a study involving 34 aphasic patients, continuous theta burst stimulation (cTBS) over the right posterior superior temporal gyrus significantly improved language performance compared to sham stimulation, as measured by the Western Aphasia Battery scores.
The mechanism behind these improvements appears to involve decreased intrinsic activity in the right fronto-thalamic-cerebellar circuit and enhanced connectivity in the right temporoparietal region, suggesting a targeted approach to language rehabilitation.
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.Zheng, K., Xu, X., Ji, Y., et al.[2023]

References

Neurochemical effects of theta burst stimulation as assessed by magnetic resonance spectroscopy. [2022]
Reproducibility of the effects of theta burst stimulation on motor cortical plasticity in healthy participants. [2022]
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]
Comparing the after-effects of continuous theta burst stimulation and conventional 1 Hz rTMS on semantic processing. [2013]
Intermittent Theta Burst Stimulation (iTBS) for Treatment of Chronic Post-Stroke Aphasia: Results of a Pilot Randomized, Double-Blind, Sham-Controlled Trial. [2021]
5 kHz Transcranial Alternating Current Stimulation: Lack of Cortical Excitability Changes When Grouped in a Theta Burst Pattern. [2020]
Safety and tolerability of theta-burst transcranial magnetic stimulation in children. [2012]
Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]
Neurobiological Correlates of Inhibition of the Right Broca Homolog during New-Word Learning. [2022]
Paired associative stimulation increases motor cortex excitability more effectively than theta-burst stimulation. [2022]
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