rTMS and Conventional Physical Therapy After Stroke

NCT01875536 | Completed Phase 2 DMC

• 1 other identifier: rTMS_Physical Therapy_stroke
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

transcranial magnetic stimulation; spasticity; physiotherapy; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from Modified Ashworth scale

  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

  at baseline, 1 month and 2 months

• change from spinal excitability via Hoffmann reflex of the median nerve

  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

  at baseline, 1 month and 2 months

Secondary Outcomes (2)

• change from Fugl-Meyer assessment

  at baseline, 1 month and 2 months

• change from cortical excitability via single transcranial magnetic stimulation

  per-session: at baseline and one hour (after physical therapy)

Other Outcomes (1)

• change from stroke specific quality of life scale

  at baseline, 1 month and 2 months

Study Arms (2)

rTMS

EXPERIMENTAL

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; Behavioral: conventional physical therapy

control

SHAM COMPARATOR

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

Interventions

rTMS 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

rTMS

conventional physical therapy 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; rTMS

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory-LANA

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 12, 2013
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

BR (1)