Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05303649

Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia

Led by Institute of Psychiatry and Neurology, Warsaw · Updated on 2026-03-31

45

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aphasia is an impairment in the ability to express and/or understand language, commonly observed after stroke to the language dominant (left) hemisphere. Despite natural tendency to spontaneous functional recovery in the first months post stroke and language improvement due to application of behavioral speech and language therapy (SLT), many aphasic patients do not achieve satisfactory level of verbal communication. The aim of the planned study is to explore the potential of the noninvasive repetitive Transcranial Magnetic Stimulation (rTMS) as a therapeutic tool for aphasia in addition to traditional behavioral therapy. In case of aphasia, studies on therapeutic effectiveness of rTMS aim to increase the activity of the language-dominant left cerebral hemisphere, which may be achieved in an indirect manner by inhibiting the activity of the opposite (right) hemisphere or in a direct manner by increasing the excitability of preserved language areas in the left hemisphere. In our study, we plan to administer the newest form of rTMS called Theta Burst Stimulation (TBS), which is safer than the conventional rTMS, even when used in the perilesional area. Computer-based neuronavigation system will be implemented to precisely localize stimulation targets, control administration of stimuli during rTMS sessions, and evaluate differences between participants regarding deviations from established stimulation points. 45 patients (all right-handed, polish native speakers, aged 18-75 years, diagnosed with non-fluent aphasia) will be enrolled in a randomized, double-blind, sham-controlled trial. Subjects will be randomly assigned to one of the three groups: 1) a group with excitatory intermittent TBS of the left hemisphere (iTBS group), 2) a group with inhibitory continuous TBS of the right hemisphere (cTBS group), 3) a group with sham TBS (sTBS group as a control group). Specific forms of stimulation will be carried out for three consecutive weeks (Monday to Friday; a total of 15 stimulation sessions). Immediately after each session of the stimulation, patients will undergo individual SLT. Assessment of language functioning will be carried out three times: before and after the therapy period, and 3 months after its completion. Results of the study will broaden knowledge about hemispherical mechanisms of language and speech recovery after stroke and provide insight into possibilities of their modulation for the purpose of post-stroke rehabilitation.

CONDITIONS

Official Title

Effects of Neuronavigated Theta Burst Stimulation in Therapy of Post-stroke Aphasia

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • First-ever left middle cerebral artery ischemic stroke confirmed by MRI
  • At least 3 months since stroke onset
  • Non-fluent aphasia with functional communication difficulties (ASRS grades 2 to 4), naming problems, and preserved everyday speech comprehension
  • Native Polish speaker
  • Right-handed before stroke
  • Signed informed consent for study participation
Not Eligible

You will not qualify if you...

  • Psychiatric or neurological disorders like dementia, depression, or alcohol dependence
  • History or signs of epilepsy or unexplained frequent loss of consciousness
  • Previous neurosurgery around the head
  • Contraindications for 1.5 T MRI such as metal implants or claustrophobia
  • Regular use of medications affecting brain excitability or neuroplasticity
  • Significant cognitive impairment limiting cooperation
  • Visual deficits that interfere with seeing therapy tasks on a computer
  • New neurological events or serious illnesses requiring therapy interruption during the study

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Trial Site Locations

Total: 1 location

1

Institute of Psychiatry and Neurology

Warsaw, Masovian Voivodeship, Poland

Actively Recruiting

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Research Team

K

Katarzyna E Polanowska, PhD

CONTACT

S

Szczepan Iwański, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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