Theta-Burst Stimulation for Language Disorders

(TAFE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Georgia State University

Disqualifiers: Learning disability, Hearing deficits, Visual deficits, others

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

Will I have to stop taking my current medications?

The trial information 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 Theta-Burst Stimulation for Language Disorders?

Research shows that intermittent theta burst stimulation (iTBS) can improve language function in people with post-stroke aphasia by enhancing activity in brain areas responsible for language. Additionally, continuous theta burst stimulation (cTBS) has been found to improve language performance by targeting specific brain regions involved in language processing. ^{1 2 3 4 5}

Is theta-burst stimulation safe for humans?

Theta-burst stimulation, including both continuous (cTBS) and intermittent (iTBS) forms, has been studied for safety in conditions like major depressive disorder. Studies have shown it is generally safe and well-tolerated, though some participants may experience mild side effects. ^{1 6 7 8 9}

How does theta-burst stimulation treatment differ from other treatments for language disorders?

Theta-burst stimulation (TBS) is unique because it uses magnetic pulses to influence brain activity, potentially improving language function in people with language disorders. Unlike traditional therapies, TBS can be applied in short sessions and targets specific brain areas involved in language processing, offering a novel approach for conditions like post-stroke aphasia. ^{1 2 5 10 11}

Research Team

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.

Inclusion Criteria

* Subjects must have a minimum of low average intellectual functioning (\>=80) on at least one subscale on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2; Wechsler, 2011) to be included.

* Within a normal range of reading skills as \>85 on the Test of Word Reading Efficiency - Second Edition (TOWRE-2; Torgesen et al., 2012) and the Woodcock-Johnson IV Tests of Achievement (WJ-IV; Schrank et al., 2014)

* Individuals with a documented history of learning disability will not be included. This will be determined via demographics questionnaire.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial magnetic stimulation (TMS) and undergo reading, language, and cognitive testing

6 weeks

Weekly visits for TMS and testing

Follow-up

Participants are monitored for changes in reading and language behavior after TMS

4 weeks

Treatment Details

Interventions

• cTBS (Behavioral Intervention)
• iTBS (Behavioral Intervention)
• Sham Stimulation (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: iTBS/Sham Experimental Treatment 2 Interventions

Adults age 18-30 with typical reading and language abilities

Group II: cTBS/Sham Experimental Treatment 2 Interventions

Adults age 18-30 with typical reading and language abilities

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Georgia State University Atlanta, GA

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Dr. Jian-Dong Li

Georgia State University

Chief Executive Officer since 2011

PhD in Biomedical Sciences from University of California, San Francisco; MD from Qingdao University School of Medicine

Dr. Steve Simonson

Georgia State University

Chief Medical Officer since 2014

MD from Medical College of Wisconsin; Master's in Health Sciences from Duke University School of Medicine

Findings from Research

In a study involving 36 multiple sclerosis patients, intermittent theta burst stimulation (iTBS) significantly improved manual dexterity, as shown by faster completion times in the nine-hole peg test and increased performance in the Box and Block Test.

However, iTBS did not have a significant impact on hand motor imagery abilities, indicating that while it can enhance physical tasks, it may not affect cognitive aspects of motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Intermittent Theta Burst Stimulation on Manual Dexterity and Motor Imagery in Patients with Multiple Sclerosis: A Quasi-Experimental Controlled Study. Azin, M., Zangiabadi, N., Iranmanesh, F., et al.[2020]

Intermittent theta burst stimulation (iTBS) applied to the left frontal lobe showed significant improvements in language abilities for participants with post-stroke aphasia, as evidenced by moderate to large effect sizes on tests like the Boston Naming Test and Semantic Fluency Test.

The study, involving 36 participants over 3 weeks, demonstrated that iTBS not only enhanced language function but also led to increased brain activation and connectivity, suggesting that this treatment may promote cortical plasticity in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation (iTBS) for Treatment of Chronic Post-Stroke Aphasia: Results of a Pilot Randomized, Double-Blind, Sham-Controlled Trial. Szaflarski, JP., Nenert, R., Allendorfer, JB., et al.[2021]

Intermittent theta-burst stimulation (iTBS) significantly improves hand function in stroke patients, particularly in those with higher baseline motor function and the presence of motor-evoked potentials (MEPs).

The study of 72 stroke patients showed that those with MEPs and better grip strength (Group A) had the greatest improvement in motor function, suggesting that iTBS effectiveness can be predicted by these factors, allowing for more tailored neurostimulation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. Lai, CJ., Wang, CP., Tsai, PY., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurochemical effects of theta burst stimulation as assessed by magnetic resonance spectroscopy. Stagg, CJ., Wylezinska, M., Matthews, PM., et al.[2022]

Intermittent theta burst stimulation (iTBS) is as effective as standard high-frequency (10 Hz) rTMS for treating treatment-resistant depression, showing non-inferiority in improving depression scores over 4-6 weeks in a study with 414 participants.

Both iTBS and 10 Hz rTMS had similar safety profiles and dropout rates, with headaches being the most common side effect, indicating that iTBS can be a viable alternative that allows for more patients to be treated in a shorter time without losing effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Blumberger, DM., Vila-Rodriguez, F., Thorpe, KE., et al.[2022]

References

1. Estonia pubmed.ncbi.nlm.nih.gov

Effects of Intermittent Theta Burst Stimulation on Manual Dexterity and Motor Imagery in Patients with Multiple Sclerosis: A Quasi-Experimental Controlled Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation (iTBS) for Treatment of Chronic Post-Stroke Aphasia: Results of a Pilot Randomized, Double-Blind, Sham-Controlled Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Interhemispheric Plasticity following Intermittent Theta Burst Stimulation in Chronic Poststroke Aphasia. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Neurochemical effects of theta burst stimulation as assessed by magnetic resonance spectroscopy. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary assessment of the therapeutic efficacy of continuous theta-burst magnetic stimulation (cTBS) in major depression: a double-blind sham-controlled study. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. [2023]

11. England pubmed.ncbi.nlm.nih.gov

The effect of theta-burst stimulation on unilateral spatial neglect following stroke: a systematic review. [2019]