Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05303649
Study type Interventional
Source Institute of Psychiatry and Neurology, Warsaw
Contact Katarzyna E Polanowska, PhD
Phone +48224582870
Email kpolanowska@ipin.edu.pl
Status Recruiting
Phase N/A
Start date September 2, 2022
Completion date December 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03993236 - Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke Phase 4
Completed NCT04069767 - Innovative Physiotherapy in Stroke Rehabilitation N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Enrolling by invitation NCT04956211 - Periodontal Treatment and Ischemic Stroke N/A
Active, not recruiting NCT05098236 - Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage N/A
Completed NCT03942588 - High-intensity Interval Training After Stroke N/A
Recruiting NCT04949334 - Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke N/A
Terminated NCT04095767 - Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke N/A
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Completed NCT01937182 - The Efficacy of Citalopram Treatment in Acute Stroke Phase 2
Completed NCT03649295 - Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke N/A
Completed NCT04233515 - Use of Oral Anticoagulants and Symptoms in Patients With Atrial Fibrillation in Örebro County
Completed NCT05102877 - Sensory Versus Motor Level Neuromuscular Electrical Stimulation N/A
Completed NCT04089917 - A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
Completed NCT05221112 - Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients N/A
Not yet recruiting NCT05035953 - Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke Phase 2
Completed NCT06326801 - Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients N/A
Not yet recruiting NCT05210088 - PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke Phase 1/Phase 2
Recruiting NCT03826030 - Transcranial Direct Current Stimulation for Post-stroke Motor Recovery Phase 2
Recruiting NCT03839810 - Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery N/A