pBFS-guided cTBS at Different Doses for Aphasia After Stroke

Summary

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.

Conditions

• Stroke
• Aphasia

Interventions

DEVICE

active 1200-pulse continuous Theta Burst Stimulation

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.

DEVICE

active 2400-pulse continuous Theta Burst Stimulation

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.

DEVICE

active 3600-pulse continuous Theta Burst Stimulation

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.

DEVICE

sham 1200-pulse continuous Theta Burst Stimulation

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.

DEVICE

sham 2400-pulse continuous Theta Burst Stimulation

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.

DEVICE

sham 3600-pulse continuous Theta Burst Stimulation

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.

Sponsors & Collaborators

• Changping Laboratory

  lead OTHER

Principal Investigators

• Hesheng Liu, PhD · Changping Laboratory

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-22

Primary Completion

2025-09-22

Completion

2025-12-22

Countries

• China

Study Locations