Advertisement

Topics

Repetitive Transcranial Magnetic Stimulation (rTMS) to Contralesional Hemisphere in Patients With Stroke for Upper Limb Recovery

2014-08-27 03:16:39 | BioPortfolio

Summary

This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a structural MRI scan for targeting stimulation and therefore structural MRI will be performed on all subjects. In addition the study intends to determine whether measures of motor tract integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor imaging can be used to clarify prognosis of motor recovery and to monitor progress with rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes will be measured immediately post treatment, and at 3 months and 6 months post treatment.

Description

PRIMARY OBJECTIVES To determine whether NBS guided 1Hz rTMS targeting the motor representation areas of hand muscles on the healthy brain hemisphere has a beneficial effect on the motor recovery of the corresponding stroke-affected muscles when combined with standardized task-oriented motor rehabilitation.

SECONDARY OBJECTIVES

1. To determine whether motor evoked potentials (MEPs) can be elicited from paretic and/or plegic muscles in patients with stroke using navigated TMS (eXimia NBS) and targeting the anatomical cortical areas representing the affected muscles.

2. To determine the correlation between existing MEPs, other TMS parameters and the clinical deficits of limb function.

3. To determine the prognostic value of MEPs and other TMS parameters in predicting motor recovery after stroke

4. To determine the diagnostic value of MEPs and other TMS parameters in monitoring the response to rehabilitation

5. To assess safety by capturing all Serious Adverse Events during both single pulse and rTMS delivery

STUDY PROCEDURES

The purpose of the study including risks and benefits will be explained to potential participants who will then be asked to sign an informed consent form. Potential participants will be screened for inclusion and exclusion criteria

The study will be performed in 2 parts. In part 1 Nexstim eXimia NBS will be utilized for neuronavigation and a third party TMS will be used for delivering the rTMS. In part 2 Nexstim eXimia NBS will be utilized together with Nexstim eXimia TMS for delivering the rTMS. Part 2 will commence once the patients participating in Part 1 have undergone the study visit 22 (see 5.1 below).

15 patients will be recruited to part 1 and 15 patients for part 2 (6 additional subjects will be recruited assuming a 20% drop out rate)

In part 1 of the study 10 subjects will be randomized to rTMS treatment and 5 subjects will be randomized to sham rTMS. Of the 10 rTMS treatment subjects, 5 will be given stimulation protocol A and 5 will be given stimulation protocol B, described below. In part 2, either stimulation protocol A or B will be chosen for continue study based on predetermined outcome criteria. In part 2, 10 subjects will receive this chosen rTMS treatment and 5 subjects will receive sham rTMS.

The study will consist of 24 study visits with the addition of 4 additional visits as needed to complete outcome assessments.

VISIT SCHEDULE

The study will be performed over 24 to 28 sessions:

1. Visit 1(Screening visit): Baseline = 3-9 months after the stroke. The purpose of this visit is to obtain informed consent for the study (if not previously obtained) and to screen subjects for inclusion and exclusion criteria.

2. Visit 2: Baseline assessment. The purpose of this visit is to establish the baseline of injury, motor status and NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres - see appendix A). Subjects will also undergo a structural MRI. The subject will then be randomized to either rTMS or to sham treatment. The baseline visit may if necessary take place on 2 separate days.

3. Visits 3-21: During these visits the patient will undergo standardized task-oriented motor rehabilitation of the hand. In addition the patient will receive the rTMS therapy according to the protocol of the group she/he was randomized into during visit 1. The visits will take place during a 6 week period, three visits per week. During each week the visits will take place each on a separate day and a maximum of two visits will take place on consecutive days. During the first visit of each week (visits 3, 6, 9, 12, 15 and 18) in addition to the rTMS and task-oriented motor rehabilitation, the patient will undergo measurement of NBS parameters (Motor tract integrity, both hemispheres).

4. Visit 22: End of the task-oriented motor rehabilitation. The purpose of the visit is to establish the extent of recovery that has occurred during the rehabilitation. The visit will take place 3-5 days after the last rTMS/rehabilitation session and includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres). 1-2 visits may be needed to complete assessment.

5) Visit 23: 1 month after the end of the rehabilitation therapy. The purpose of the visit is to determine whether any changes in motor function or NBS parameters have occurred within 1 month of ending therapy. The assessment includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres). 1-2 visits may be needed to complete assessment.

6) Visit 24: 6 months after end of the rehabilitation therapy. The purpose of this visit is to determine the long-term rehabilitation success. The assessment includes functional motor testing and evaluation of NBS parameters (Hand motor mapping and motor tract integrity, both hemispheres. In patients experience a new stroke or TIA during this time, only the data prior to the event will be used in the analysis. 1-2 visits may be needed to complete assessment.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Stroke

Intervention

repetitive transcranial magnetic stimulation to contralesional hemisphere

Location

The Rehabilitation Institute of Chicago
Chicago
Illinois
United States
60611

Status

Recruiting

Source

Rehabilitation Institute of Chicago

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:39-0400

Clinical Trials [3188 Associated Clinical Trials listed on BioPortfolio]

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity

Spasticity is a common complication of stroke affecting quality of life. Spasticity involves exaggerated stretch reflexes that create stiffness in muscles with associated loss of motion a...

Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis

This study will compare the effectiveness of different polarities of transcranial direct current stimulation paired with intensive motor training in recovery of upper extremity function in...

Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke

The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on reducing u...

Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis

The study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network an...

Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation at the Subacute Phase of Ischaemic Stroke

The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation at the subacute phase of stroke (between day 7 and day 14) improves significantly arm motility a...

PubMed Articles [8079 Associated PubMed Articles listed on BioPortfolio]

Low-Frequency Repetitive Transcranial Magnetic Stimulation for Stroke-Induced Upper Limb Motor Deficit: A Meta-Analysis.

This meta-analysis aimed to evaluate the therapeutic potential of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) over the contralesional hemisphere on upper limb motor recovery a...

Effects of Navigated Repetitive Transcranial Magnetic Stimulation After Stroke.

The purpose of this study was to test the effects of navigated repetitive transcranial magnetic stimulation, delivered in different modes, on motor impairments and functional limitations after stroke.

Efficacy of repetitive transcranial magnetic stimulation for Tourette syndrome: A systematic review and meta-analysis.

While previous studies have investigated the effect of repetitive transcranial magnetic stimulation (rTMS) in treating Tourette syndrome (TS), the results remain inconclusive.

The influence of the repetitive transcranial magnetic stimulation on sleep quality in depression.

Repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. In this study we investigated whether the depression-related insomnia is modulated by this therapeutic method.

Bi-hemispheric repetitive transcranial magnetic stimulation for upper limb motor recovery in chronic stroke: A feasibility study.

Medical and Biotech [MESH] Definitions

The electrical response evoked in a muscle or motor nerve by electrical or magnetic stimulation. Common methods of stimulation are by transcranial electrical and TRANSCRANIAL MAGNETIC STIMULATION. It is often used for monitoring during neurosurgery.

Measurable changes in activities in the CEREBRAL CORTEX upon a stimulation. A change in cortical excitability as measured by various techniques (e.g., TRANSCRANIAL MAGNETIC STIMULATION) is associated with brain disorders.

A technique of brain electric stimulation therapy which uses constant, low current delivered via ELECTRODES placed on various locations on the scalp.

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the CEREBRAL CORTEX. It is coupled with ELECTROMYOGRAPHY response detection to assess cortical excitability by the threshold required to induce MOTOR EVOKED POTENTIALS. This method is also used for BRAIN MAPPING, to study NEUROPHYSIOLOGY, and as a substitute for ELECTROCONVULSIVE THERAPY for treating DEPRESSION. Induction of SEIZURES limits its clinical usage.

More From BioPortfolio on "Repetitive Transcranial Magnetic Stimulation (rTMS) to Contralesional Hemisphere in Patients With Stroke for Upper Limb Recovery"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Radiology
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...


Searches Linking to this Trial