pBFS-guided Dual-target cTBS for Aphasia After Stroke

Conditions

• Aphasia
• Stroke

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 combination of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, which will be repeated once more (a total of 2400 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 combination 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, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.

Study Details

The objective of this trial is to evaluate the effectiveness and safeness 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) for language function recovery in post-stroke aphasic patients.

Key Dates

First listed

Jul 24, 2023

Start date

Jul 28, 2023

Status verified

Aug 2024

Primary completion

Aug 1, 2025

Completion

Dec 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

• Ruiqi Pan
  010-80726688
  [email protected]

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