pBFS-guided cTBS at Different Doses for Aphasia After Stroke

Sponsor
Changping Laboratory
Study ID
NCT05969548
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • active 1200-pulse 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.
  • active 2400-pulse continuous Theta Burst Stimulation — DEVICE
    Each patient will receive two 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
  • active 3600-pulse continuous Theta Burst Stimulation — DEVICE
    Each patient will receive two 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
  • sham 1200-pulse 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.
  • sham 2400-pulse continuous Theta Burst Stimulation — DEVICE
    Each patient will receive two sham 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
  • sham 3600-pulse continuous Theta Burst Stimulation — DEVICE
    Each patient will receive two sham 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 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 different doses of continuous Theta Burst Stimulation (cTBS) over the right Superior Frontal Gyrus (SFG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-stroke aphasia.

Key Dates

First listed
Aug 1, 2023
Start date
Sep 22, 2023
Status verified
Sep 2024
Primary completion
Sep 22, 2025
Completion
Dec 22, 2025

Study Design

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

Arms

  • Active Comparator: active 1200-pulse cTBS group
    active 1200-pulse cTBS combined with speech language therapy
  • Active Comparator: active 2400-pulse cTBS group
    active 2400-pulse cTBS combined with speech language therapy
  • Active Comparator: active 3600-pulse cTBS group
    active 3600-pulse cTBS combined with speech language therapy
  • Sham Comparator: sham 1200-pulse cTBS group
    sham 1200-pulse cTBS combined with speech language therapy
  • Sham Comparator: sham 2400-pulse cTBS group
    sham 2400-pulse cTBS combined with speech language therapy
  • Sham Comparator: sham 3600-pulse cTBS group
    sham 3600-pulse 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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