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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS Group | Experimental | Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol. |
|
| Sham rTMS Group | Sham Comparator | Participants received botulinum toxin-A treatment, conventional physical therapy, and sham repetitive transcranial magnetic stimulation (sham rTMS). The sham procedure was designed to mimic active stimulation without delivering therapeutic stimulation. |
|
| cTBS Group | Experimental | Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spasticity Assessed by Modified Ashworth Scale (MAS) | Spasticity severity was assessed using the Modified Ashworth Scale. | Baseline, 1 Month, and 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Recovery Assessed by Brunnstrom Staging | Motor recovery of the upper extremity and hand was assessed using Brunnstrom staging. | Baseline, 1 Month, and 3 Months |
| Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damla CANKURTARAN, Associate Professor, MD | Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic | Ankara | Ankara | 06010 | Turkey (Türkiye) |
Individual participant data will not be shared due to privacy and confidentiality considerations.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Participants were assigned to parallel groups receiving different transcranial magnetic stimulation protocols in combination with standard treatment.
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|
| Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS) | Device | 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) | Device | 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. |
|
Upper extremity motor function was assessed using the Fugl-Meyer Assessment. |
| 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. | 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. | Baseline, 1 Month, and 3 Months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |