Post-stroke Spasticity of the Upper Limb
Conditions
Keywords
transcranial magnetic stimulation, stroke, upper limb spasticity, TMS, Botulinum Toxin-A, Rehabilitation, Neurorehabilitation, rTMS
Brief summary
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.
Detailed description
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).
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
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.
Sponsors
Asya ÖZCAN KAVCI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants were assigned to parallel groups receiving different transcranial magnetic stimulation protocols in combination with standard treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stroke (ischemic or hemorrhagic) * Time since stroke onset between 3 and 24 months * Age between 18 and 80 years * Upper extremity motor recovery at Brunnstrom Stages 3-5 * Spasticity in the elbow, wrist, or finger flexor muscle groups of the upper extremity with a Modified Ashworth Scale (MAS) score between +1 and 3 * Receipt of botulinum toxin-A injection to the affected upper extremity within the previous week
Exclusion criteria
* History of epileptic seizures, epileptiform EEG findings, increased seizure risk, or use of antiepileptic medication * Presence of implanted metallic or electronic devices (e.g., cardiac pacemaker, intrathecal baclofen pump) * Pregnancy or lactation * Presence of neurological disorders other than stroke * History of cranial surgery * Orthopedic conditions or previous orthopedic surgery limiting upper extremity movement * Severe upper extremity spasticity (MAS \>3) or presence of contracture * Uncontrolled hypertension, advanced heart failure (NYHA Class III-IV), chronic obstructive pulmonary disease (COPD), active infection, severe hepatic failure, or severe renal failure * History of malignancy * Severe cognitive impairment (Mini-Mental State Examination score \<24) * Severe aphasia or communication disorder that would interfere with participation in the study * Botulinum toxin injection administered to the upper extremity in a separate treatment session within the previous 3 months * Any change in medication type or dosage within the previous month for oral medications used in the management of spasticity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spasticity Assessed by Modified Ashworth Scale (MAS) | Baseline, 1 Month, and 3 Months | Spasticity severity was assessed using the Modified Ashworth Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Recovery Assessed by Brunnstrom Staging | Baseline, 1 Month, and 3 Months | Motor recovery of the upper extremity and hand was assessed using Brunnstrom staging. |
| Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment | Baseline, 1 Month, and 3 Months | Upper extremity motor function was assessed using the Fugl-Meyer Assessment. |
| Change in Upper Extremity Use Assessed by Motor Activity Log-28 | Baseline, 1 Month, and 3 Months | The frequency and quality of upper extremity use in daily activities were assessed using the Motor Activity Log-28. |
| Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale | Baseline, 1 Month, and 3 Months | Anxiety and depression levels were assessed using the Hospital Anxiety and Depression Scale. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORDamla CANKURTARAN, Associate Professor, MD
Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
Outcome results
None listed