pBFS-guided Multi-target cTBS for Aphasia After Stroke

Sponsor
Changping Laboratory
Study ID
NCT05957445
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • active continuous Theta Burst Stimulation — DEVICE
    Each patient will receive a series of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, and subsequently a 600-pulse cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.
  • sham continuous Theta Burst Stimulation — DEVICE
    Each patient will receive a series of stimulation sequences，including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, and subsequently a 600-pulse sham cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.

Study Details

In this study, a randomized, double-blind, parallel-controlled trial was employed to evaluate the effectiveness and safety of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) and the superior frontal gyrus (SFG) for language function recovery in post-stroke aphasic patients.

Key Dates

First listed
Jul 24, 2023
Start date
Aug 23, 2023
Status verified
Jul 2024
Primary completion
Jun 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: active cTBS group
    active cTBS combined with speech language therapy
  • Sham Comparator: sham cTBS group
    sham cTBS combined with speech language therapy

Primary Outcome Measure

Change in the Western Aphasia Battery scores [ Time Frame: baseline, end of the 3-week therapy ]

Central Contacts

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