Status:
COMPLETED
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Stroke
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to investigate the effects of intermittent theta burst stimulation primed with continous theta burst stimulation (cTBS), on top of a standard robot-assisted training (RAT) on ...
Detailed Description
Intermittent theta burst stimulation (iTBS) delivered to the affected primary motor cortex (M1) appears to enhance the brain response to rehabilitative intervention in patients with stroke. However, i...
Eligibility Criteria
Inclusion
- with a diagnosis of a unilateral ischemic or hemorrhagic stroke;
- with stroke onset more than 6 months;
- from 18 to 75 years old;
- with mild to moderate impairment of upper limb functions due to stroke, measured using the Hong Kong Version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) from level 2 to level 7;
- be able to understand verbal instruction and follow one-step commands;
- be able to give informed consent to participate;
Exclusion
- any contraindications to rTMS/TBS, such as unstable medical condition, history of epileptic seizures, metal implants in vivo (eg, pacemaker, artificial cochlear, and implant brain stimulator), and a history of receiving craniotomy;
- previous diagnosis of any neurological disease excluding stroke;
- presence of any sign of cognitive problems (Abbreviated mental test Hong Kong version \< 6/10);
- patients with extreme spasticity in any hemiplegic upper limb joint (Modified Ashworth score \> 2) or severe pain that hinder the upper limb motor training;
- with other notable impairment of the upper limb affected by stroke, eg, recent fracture, severe osteoarthritis, congenital upper limb deformity
- any sign of anxiety or depression, as assessed by the Hospital Anxiety and Depression Scale.
- concurrent participation in an upper limb rehabilitation program or a medicine trial.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04034069
Start Date
September 9 2019
End Date
August 1 2021
Last Update
August 30 2021
Active Locations (1)
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1
The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Hong Kong, Hong Kong