Topics

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

2014-10-27 22:08:21 | BioPortfolio

Summary

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 and functional control. Traditional treatments involves range of motion, medications, and sometimes surgery. Each of these has its own limitations, which has invited exploration of alternative modes of treatment. One such treatment with the potential to benefit spasticity is repetitive Transcranial Magnetic Stimulation (rTMS).

The purpose of this study is to determine whether patients with upper limb spasticity as a consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper limb function.

Description

The purpose of this pilot study is to evaluate the efficacy of rTMS versus placebo for spasticity reduction in a cross-over design in 6 people with stroke.

Our research question is: In patients with upper extremity spasticity as a consequence of chronic stroke, does stimulation of the contralesional motor cortex with low-frequency (inhibitory) rTMS lead to reduction of spasticity and thereby clinical improvement in upper extremity function? Our rationale is that the pathophysiology of post-stroke spasticity is primarily driven by ensuant cortical derangement, and further, that this derangement can be mitigated to a clinically meaningful extent by proper utilization of rTMS directed at these foci. Optimized rTMS treatment protocols may even achieve efficacy that surpasses current mainstays of spasticity management.

Patients will be randomly assigned to receive either rTMS or placebo during their first treatment arm and then cross-over to receive the opposite treatment at the second treatment arm. A washout period of one month will occur between treatment arms. Each treatment arm will consist of 5 daily treatment sessions. One treatment session will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere. Sham rTMS intensity will be 0% but with a similar sound and scalp sensation. Assessments will be made at each session, and will be conducted at baseline, posttest, and one-month follow-up. The follow-up test will serve as the baseline for the next treatment arm. That is, after follow-up, patients will cross-over to receive the opposite treatment in the same format. Safety has already been demonstrated for our protocol. Data will be analyzed with methods appropriate to a single-subject crossover design (visual analysis, confidence intervals and 2-Standard Deviation bandwidth).

The primary outcome that we will measure is reduction of spasticity at the fingers and wrist. A secondary outcome of interest is functional improvement of the spastic upper limb.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Spasticity

Intervention

repetitive Transcranial Magnetic Stimulation (rTMS), Sham repetitive Transcranial Magnetic Stimulation

Location

University of Minnesota, Clinical and Translational Science Institute
Minneapolis
Minnesota
United States
55414

Status

Not yet recruiting

Source

University of Minnesota - Clinical and Translational Science Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-10-27T22:08:21-0400

Clinical Trials [3589 Associated Clinical Trials listed on BioPortfolio]

Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation

This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation on decision-making and smoking behavior.

A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients

This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS) on cognition and long-term clinical outcomes of bipolar patients.

Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms

This study will be comprised of two Phases. Phase 1 is a randomized, double-blinded study testing repetitive Transcranial Magnetic Stimulation (rTMS) versus sham (20 treatments over 4 week...

The Effects of Repetitive Transcranial Magnetic Stimulation in Healthy Human Subjects

It has been suggested that the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) are mediated through changes in cortical inhibition (CI). However, in healthy subj...

Repetitive Transcranial Magnetic Stimulation (rTMS) for Neuropathy

The goal of this research study is to learn if using a type of therapy called repetitive transcranial magnetic stimulation (rTMS) can help improve chemotherapy-related peripheral neuropath...

PubMed Articles [6835 Associated PubMed Articles listed on BioPortfolio]

Antidepressant Effect of Adjunct Repetitive Transcranial Magnetic Stimulation in Inpatients 60 Years and Older.

Repetitive transcranial magnetic stimulation (rTMS) is now an established, safe, and effective treatment for adults with depression. However, specific research in rTMS for use in elderly patients with...

Excess Significance Bias in Repetitive Transcranial Magnetic Stimulation Literature for Neuropsychiatric Disorders.

Repetitive transcranial magnetic stimulation (rTMS) has been widely tested and promoted for use in multiple neuropsychiatric conditions, but as for many other medical devices, some gaps may exist in t...

Static and dynamic network properties of the repetitive transcranial magnetic stimulation target predict changes in emotion regulation in obsessive-compulsive disorder.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique to treat psychiatric disorders, such as obsessive-compulsive disorder (OCD). However, the rTMS response ...

Implementation of intermittent theta burst stimulation compared to conventional repetitive transcranial magnetic stimulation in patients with treatment resistant depression: A cost analysis.

Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based treatment for depression that is increasingly implemented in healthcare systems across the world. A new form of rTMS called int...

Repetitive transcranial magnetic stimulation for cognitive impairment in Alzheimer's disease: a meta-analysis of randomized controlled trials.

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive brain stimulation technique for Alzheimer's disease (AD). rTMS, with high- or low-frequency, is thought to enhance or inhibit the c...

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.

A region of DNA that is highly polymorphic and is prone to strand breaks, rearrangements or other MUTATIONS because of the nature of its sequence. These regions often harbor palindromic, or repetitive sequences (REPETITIVE SEQUENCES, NUCLEIC ACID). Variability in stability of the DNA sequence is seen at CHROMOSOME FRAGILE SITES.

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) Treatment of Post-Stroke Spasticity"

Quick Search

Relevant Topics

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...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...


Searches Linking to this Trial