Repetitive Transcranial Magnetic Stimulation in Post Stroke Upper Limb Spasticity

March 31, 2022 updated by: ilker şengül, Izmir Katip Celebi University

Effect of Repetitive Transcranial Magnetic Stimulation Over Contralesional Dorsal Premotor Cortex on Post Stroke Upper Limb Spasticity

The reticulospinal pathway (RSP) is at the center of spasticity mechanism. The RSP indirectly synapses with motor neurons via interneurons in the ventromedial intermediate zone in both halves of the spinal cord, and directly synapses with motor neurons of proximal extremity muscles. The main motor cortex region controlling unilateral RSP is the premotor cortex. That is, a single limb is represented in both premotor cortices. This suggests theoretically that if the corticoreticular pathway controlling RSP is modulated by dorsal premotor cortex stimulation, there may be a change in the regulation of the intraspinal network regulating the stretch reflex. Therefore, the hypothesis in this study is that the application of repetitive transcranial magnetic stimulation (rTMS) over the contralesional dorsal premotor cortex in chronic stroke patients changes the severity of spasticity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spasticity is a disorder characterized by increase in velocity-related muscle tone as a part of upper motor neuron syndrome. Although the mechanisms underlying stroke-related spasticity have not been fully understood, the current view is that spasticity is related to an imbalance between descending excitatory and inhibitory systems that regulate spinal stretch reflex and associated with abnormal intraspinal processes. The reticulospinal pathway (RSP) is at the center of this mechanism called cortical disinhibition. The dorsal RSP, which has an inhibitory effect on the spinal stretch reflex, originates from the medullary reticular formation and is under cortical control. In contrast to dorsal RSP, medial RSP which is not under the control of motor cortex originates from pontine reticular formation,and has an excitatory effect on spinal stretch reflex. The main motor cortex region controlling unilateral dorsal RSP is the premotor cortex. Unilateral RSP indirectly synapses with motor neurons via interneurons in the ventromedial intermediate zone in both halves of the spinal cord, and directly synapses with motor neurons of proximal extremity muscles. That is, a single limb is represented in both premotor cortices. This suggests theoretically that if the corticoreticular pathway controlling dorsal RSP is modulated by dorsal premotor cortex stimulation, there may be a change in the regulation of the intraspinal network regulating the stretch reflex. Furthermore, in stroke patients with severe motor impairment, the relationship between high cortical centers and the primary motor cortex is more in the form of facilitation rather than interhemispheric inhibition between the primary motor cortices. In other words, stimulation of one side premotor cortex may affect motor impairment and spasticity by affecting primary and high motor cortical centers of both hemispheres and both halves of the spinal cord. Therefore, the hypothesis in this study is that the application of repetitive transcranial magnetic stimulation (rTMS) over the contralesional dorsal premotor cortex in chronic stroke patients changes the severity of spasticity. Based on this hypothesis, our aim is to investigate the effect of rTMS over the contralesional dorsal premotor cortex on the severity of spasticity in patients with chronic stroke with moderate to severe upper extremity spasticity.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35360
        • İlker Şengül

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years
  • Stroke history ≥ 1 year
  • Having a first stroke
  • Grade 2 or 3 muscle tone according to the Modified Ashworth Scale (MAS) assessment in at least one of the elbow, wrist and finger flexors
  • Signed consent to participate in the study

Exclusion Criteria:

  • To have a clinical condition (metallic implant, cardiac pace, pregnancy, breastfeeding, claustrophobia, epilepsy, head trauma, cranial operation history) that will constitute a contraindication to transcranial magnetic stimulation
  • Presence of malignancy
  • Pregnancy or breastfeeding
  • Non-stroke disease or lesion affecting the sensorimotor system
  • Presence of pump/shunt
  • Advanced cognitive impairment
  • To have been rehabilitated in the last 3 months
  • Botulinum toxin injection in the last 3 months
  • Taking systemic antispastic drugs (Patients taking these drugs may be included in the study after a period of at least 3 times the half-life of the drug used if they agree to quit)
  • Previously treated with TMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Excitatory repetitive transcranial magnetic stimulation group
One session of repetitive transcranial magnetic stimulation (rTMS) treatment with 10 Hz frequency will be applied to the contralesional dorsal premotor cortex. Application will be performed with Neurosoft-Neuro MS / D device. 90% of the motor threshold will be used in the stimulation. Stimulation is planned for a total of 15 minutes and a total of 1500 beats in the form of a 5 seconds 10 Hz stimulation followed by a 25 seconds interval.
Device: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment.
Experimental: Inhibitory repetitive transcranial magnetic stimulation group
One session of repetitive transcranial magnetic stimulation (rTMS) treatment at 1 Hz frequency will be applied to the contralesional dorsal premotor cortex. Application will be performed with Neurosoft-Neuro MS / D device. 90% of the motor threshold will be used in the stimulation. Stimulation is planned for a total of 25 minutes and a total of 1500 beats in the form of 1 Hz stimulation.
Device: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment.
Sham Comparator: Sham repetitive transcranial magnetic stimulation group
Single session of sham application for a total of 25 minutes. Sham application will be performed by holding the probe of the device vertically to the vertex. The device will be operated at the lowest operating power of 1 to produce the same stimulation sounds like the active application. The device operating at this power is not likely to give any stimulation due to the probe being held upright.
Device: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: Pre-intervention (baseline) and immediately after intervention (post-intervention), up to 45 minutes
The modified Ashworth Scale is a scale that clinically evaluates the presence and severity of muscle tone increase. It is an ordinal scale that evaluates spasticity at six levels between 0 and 4 (0, 1, 1+, 2, 3, 4). The severity of spasticity increases as the score increases. Score 0 indicates no increase in muscle tone, while score 4 indicates that the affected part is rigid. Six levels between 0 and 5 (0, 1, 2, 3, 4, 5) will be used in statistical analysis. The score of 1+ will be treated as 2, 2 as 3, 3 as 4 and 4 as 5.
Pre-intervention (baseline) and immediately after intervention (post-intervention), up to 45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
F wave parameters
Time Frame: Pre-intervention (baseline) and immediately after intervention (post-intervention), up to 45 minutes
F-wave is one of the late responses caused by antidromic stimulation of alpha motor neurons. It occurs following supramaximal electrical stimulation of peripheral motor nerves following M response. The F wave indicates the transmission from the stimulated point to the motor neuron and back to the recording electrode. Increased F wave frequency, increased F / M ratio and amplitude has been considered to indicate the increased motor neuron excitability.
Pre-intervention (baseline) and immediately after intervention (post-intervention), up to 45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2019

Primary Completion (Actual)

June 27, 2021

Study Completion (Actual)

June 27, 2021

Study Registration Dates

First Submitted

August 16, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-KAE-0292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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