pBFS-guided cTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke

Sponsor
Changping Laboratory
Study ID
NCT05999318
Status
Recruiting
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Conditions

  • Aphasia
  • Stroke, Ischemic

Eligibility Criteria

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

Interventions

  • active continuous Theta Burst Stimulation — DEVICE
    Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
  • sham continuous Theta Burst Stimulation — DEVICE
    Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.

Study Details

The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Superior Temporal Gyrus (STG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.

Key Dates

First listed
Aug 21, 2023
Start date
Nov 7, 2023
Status verified
Aug 2024
Primary completion
Aug 20, 2025
Completion
Aug 20, 2026

Study Design

Enrollment
40 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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