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

June 6, 2013
June 11, 2013
November 2011
November 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01875536 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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
Same as current
 
rTMS and Conventional Physical Therapy After Stroke
Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • 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.
  • 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
    Interventions:
    • Device: rTMS
    • Behavioral: conventional physical therapy
  • 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
    Intervention: Behavioral: conventional physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01875536
rTMS_Physical Therapy_stroke
Yes
Kátia Monte-Silva, Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Not Provided
Not Provided
Universidade Federal de Pernambuco
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP