rTMS and Conventional Physical Therapy After Stroke

Stroke Clinical Trial

Official title:

Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875536
• Other study ID #: rTMS_Physical Therapy_stroke
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2013
• Last updated: June 11, 2013
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Given previous evidence that non invasive brain stimulation enhances the effects of conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with conventional physical therapy (VRT) would be superior to physical therapy in improving upper limb function and quality of life with chronic stroke individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• stroke onset = 6 months;

• muscle tone at the wrist with a modified Ashworth scale (MAS) score between 1+ and 3;

• minimum age of 30 years old and maximum age of 75 years;

• absence of cognitive impairment, as determined by the cut-off scores on the Mini-mental state exam

Exclusion Criteria:

• history of seizure or cerebral aneurism;

• antispasticity drugs within 6 months before enrollment;

• previous surgery involving metallic implants;

• unstable vital signs;

• other neurological diseases

• aphasia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• rTMS
The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the motor cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 1Hz on the uninjured hemisphere by stroke; 1500 pulses with an intensity of 90% of MT 10 sessions of rTMS, one per day, always before conventional physical therapy

Behavioral:
• conventional physical therapy
The physical therapy program was composed of the activities of flexibility, transfer and posture, strength, coordination, balance, and sensory stimulation. The physical therapy was applied for about 30 minutes, three days per week.

Locations

Country	Name	City	State
Brazil	Applied Neuroscience Laboratory-LANA	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from stroke specific quality of life scale	the stroke specific quality of life scale (SSQOL) is used to provide an assessment of health-related quality of life specific to patients with stroke. The scale is a self-report (reference to the past two weeks) containing 49 items distributed into 12 domains (mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking and personality), rated on a 5-point scale. The total score (maximum 245) and the upper extremity function scores (maximum of 25) can be considered for analyses. The Brazilian version of the SSQOL was used in this study	at baseline, 1 month and 2 months	No
Primary	Change from Modified Ashworth scale	Modified Ashworth scale (MAS) uses a 6-point scale to score the average resistance to passive movement for each joint. In this study, the tonus of the wrist flexor muscles was tested	at baseline, 1 month and 2 months	No
Primary	change from spinal excitability via Hoffmann reflex of the median nerve	assess the effects of the intervention (rTMS and physical therapy) on spinal excitability as measured by the change The Hmax/Mmax ratio (calculated by dividing the maximal amplitude of the H wave by that of the M wave in median nerve) before (baseline), after treatment and after follow-up	at baseline, 1 month and 2 months	No
Secondary	change from Fugl-Meyer assessment	The Fugl-Meyer assessment (FMA) is considered the gold standard for evaluating the motor function recovery. It is designed to assess motor functioning, balance, sensation, and joint functioning. It is applied within clinical and in research contexts to determine the disease severity, describe motor recovery, and plan and assess interventions. In the present study, the 33-item of the UL section was employed. The items are rated on 3-point ordinal scale, as follows: 0= unable to perform; 1= partial ability to perform; and 2= near normal ability to perform. The UL subscale evaluates motor function recovery in six domains: flexor and extensor synergies, non-synergic movements, wrist and hand movements, and coordination and speed	at baseline, 1 month and 2 months	No
Secondary	change from cortical excitability via single transcranial magnetic stimulation	assess the effects of the intervention (rTMS and physical therapy) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after each session	per-session: at baseline and one hour (after physical therapy)	No