rTMS and Conventional Physical Therapy After Stroke

NCT ID: NCT01875536

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

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

conventional physical therapy

Intervention Type: BEHAVIORAL

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.

control

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

Group Type: SHAM_COMPARATOR

conventional physical therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Kátia Monte-Silva

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Applied Neuroscience Laboratory-LANA

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

rTMS_Physical Therapy_stroke

Identifier Type: -

Identifier Source: org_study_id