rTMS and Conventional Physical Therapy After Stroke

Universidade Federal de Pernambuco

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Device: rTMS; Behavioral: conventional physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01875536

rTMS_Physical Therapy_stroke

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

rTMS

Experimental group

Description:

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

Treatment:

Behavioral: conventional physical therapy

Device: rTMS

control

Sham Comparator group

Description:

The control group received sham stimulation (same area as the experimental group) in 10 sessions, 3 days per week, and conventional physical therapy

Treatment:

Behavioral: conventional physical therapy