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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv8
  2. Notable Primary and study completion dates: Dec 2025 to Dec 2027v7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Minor Start date changed from estimate of Jul 15, 2022 to Sep 2, 2022v5
  5. Minor Start date: Jul 1, 2022 to Jul 15, 2022v4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2022 to Jul 1, 2022
    • Study sites: 0 to 1
    v3
  2. Minor Secondary endpoint revised
    • Publications: 10 to 11
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05303649
Lead Sponsor Institute of Psychiatry and Neurology, Warsaw
Conditions
(from sponsor)
Stroke, Ischemic, Aphasia Non Fluent
Related terms Aphasia, Aphasia, Broca, Ischemic Stroke, Stroke
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov