rTMS and Conventional Physical Therapy After Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01875536
First received: June 6, 2013
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Device: rTMS
Behavioral: conventional physical therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Change from Modified Ashworth scale [ Time Frame: at baseline, 1 month and 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at baseline, 1 month and 2 months ] [ Designated as safety issue: No ]
    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:
  • change from Fugl-Meyer assessment [ Time Frame: at baseline, 1 month and 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: per-session: at baseline and one hour (after physical therapy) ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • change from stroke specific quality of life scale [ Time Frame: at baseline, 1 month and 2 months ] [ Designated as safety issue: No ]
    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


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.
Sham Comparator: control
The control group received sham stimulation (same area as the experimental group) in 10 sessions, 3 days per week, and 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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875536

Locations
Brazil
Applied Neuroscience Laboratory−LANA
Recife, Pernambuco, Brazil, 50740-560
Sponsors and Collaborators
Universidade Federal de Pernambuco
  More Information

No publications provided

Responsible Party: Kátia Monte-Silva, Professor, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01875536     History of Changes
Other Study ID Numbers: rTMS_Physical Therapy_stroke
Study First Received: June 6, 2013
Last Updated: June 11, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Pernambuco:
transcranial magnetic stimulation
spasticity
physiotherapy
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014