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}

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

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 Nearby Select from list below to view details:

Georgia State University Atlanta, GA

Who Is Running the Clinical Trial?

Georgia State University Lead Sponsor

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] Intermittent theta burst stimulation (iTBS) is a repetitive transcranial magnetic stimulation (rTMS) protocol that influences cortical excitability and motor function recovery.

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] 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

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] To identify the effective predictors for therapeutic outcomes based on intermittent theta-burst stimulation (iTBS).

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

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.

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] 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.

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

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

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] 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.

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] 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.

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

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.

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] 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.

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

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.