rTMS and Conventional Physical Therapy After Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Device: rTMS; Behavioral: conventional physical therapy

• Registration Number: NCT01875536
• Lead Sponsor: Universidade Federal de Pernambuco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-11
• Last Update Submitted: 2013-06-11
• Study First Posted: 2013-06-12
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS	rTMS	The experimental group received rTMS to the primary motor cortex of the unaffected side in 10 sessions, 3 days per week, and conventional physical therapy
rTMS	conventional physical therapy	The experimental group received rTMS to the primary motor cortex of the unaffected side in 10 sessions, 3 days per week, and conventional physical therapy
control	conventional physical therapy	The control group received sham stimulation (same area as the experimental group) in 10 sessions, 3 days per week, and conventional physical therapy

Primary Outcome Measures

Name	Time	Method
Change from Modified Ashworth scale	at baseline, 1 month and 2 months	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
change from spinal excitability via Hoffmann reflex of the median nerve	at baseline, 1 month and 2 months	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

Secondary Outcome Measures

Name	Time	Method
change from Fugl-Meyer assessment	at baseline, 1 month and 2 months	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
change from cortical excitability via single transcranial magnetic stimulation	per-session: at baseline and one hour (after physical therapy)	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

Trial Locations

Locations (1)

Applied Neuroscience Laboratory-LANA; 🇧🇷 Recife, Pernambuco, Brazil