Post-stroke upper limb spasticity is an important condition that negatively affects motor recovery, upper limb functions, and activities of daily living. Multimodal treatment approaches are recommended in the management of spasticity. In recent years, the effects of transcranial magnetic stimulation (TMS) on upper limb functions and spasticity have been investigated. However, the clinical effects of different TMS protocols combined with botulinum toxin-A (BTX-A) treatment and which protocol may be more effective remain unclear. The aim of this observational study is to compare the clinical effects of different TMS protocols in patients with post-stroke upper limb spasticity receiving BTX-A treatment and to evaluate the most appropriate TMS protocol.
As part of the study, patients who received botulinum toxin type A (BTX-A) injections for upper extremity spasticity following stroke were evaluated using different TMS protocols. All patients received a standard conventional physical therapy program. TMS sessions were conducted using an inhibitory protocol, with a total of 10 sessions administered to the contralateral hemisphere at least 3 days per week. Clinical evaluations were performed at baseline, at 1 month, and at 3 months. Thus, the early and long-term clinical outcomes of treatment were investigated. Spasticity was assessed using the Modified Ashworth Scale (MAS), motor improvement using the Brunnstrom staging system, upper extremity motor function using the Fugl-Meyer Assessment, and upper extremity use in activities of daily living using the Motor Activity Log-28 (MAL-28). Additionally, patients' anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Repetitive transcranial magnetic stimulation (rTMS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol. Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
Sham repetitive transcranial magnetic stimulation (sham rTMS) was administered using procedures designed to mimic active stimulation without delivering therapeutic magnetic stimulation. Treatment was provided in combination with botulinum toxin-A injections and conventional physical therapy.
Continuous theta burst stimulation (cTBS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol. Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic
Ankara, Ankara, Turkey (Türkiye)
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Spasticity severity was assessed using the Modified Ashworth Scale.
Time frame: Baseline, 1 Month, and 3 Months
Change in Motor Recovery Assessed by Brunnstrom Staging
Motor recovery of the upper extremity and hand was assessed using Brunnstrom staging.
Time frame: Baseline, 1 Month, and 3 Months
Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
Upper extremity motor function was assessed using the Fugl-Meyer Assessment.
Time frame: Baseline, 1 Month, and 3 Months
Change in Upper Extremity Use Assessed by Motor Activity Log-28
The frequency and quality of upper extremity use in daily activities were assessed using the Motor Activity Log-28.
Time frame: Baseline, 1 Month, and 3 Months
Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
Anxiety and depression levels were assessed using the Hospital Anxiety and Depression Scale.
Time frame: Baseline, 1 Month, and 3 Months
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