Effectiveness of Transcranial Magnetic Stimulation in Subacute Stroke Patients With Severe Upper Limb Paresis

NCT05505201 | Terminated

• 1 other identifier: 2022-TDU-TIPF-0004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

There has been A-level evidence for the effectiveness of inhibitory rTMS of the contralesional M1 hand region in stroke patients in the acute stage. However, it has been reported to be ineffective in the chronic stage. In addition, it has been reported that the patient group benefiting from rTMS is mostly those with moderate to mild motor impairment. In contrast, a recent randomized controlled study has reported that ipsilesional excitatory rTMS or contra-lesional inhibitory rTMS may also have positive effects in stroke patients with severe upper limb motor impairment. The aim of this study is to investigate the effect of inhibitory repetitive transcranial magnetic stimulation applied to the contralesional primary motor cortex, by using the rTMS parameters specified in the current recommendation guide, on motor function, activities of daily living, and quality of life in subacute stroke patients with severe upper limb motor impairment.

Conditions

Stroke Rehabilitation

Keywords

Stroke; Upper limb impairment; Repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Fugl-Meyer Assessment for Upper Extremity

  The Fugl-Meyer Assessment for upper extremity (FMA-UE) is a widely used scale for motor recovery of the upper limb after stroke. FMA-UE comprises four domains (shoulder-arm, wrist, hand, and coordination-speed) developed to measure the severity of motor impairment from synergy to isolated voluntary movement. Scoring is based on direct observation of performance. Each item is scored on a three-point ordinal scale between 0 and 2 (0=cannot perform; 1=partially performs; 2=performs fully) according to performance. The score for an individual range between 0 and 66. The higher the score, the lower the motor impairment.

  (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 15th session, each session is 1 day), and (3) 4 weeks after the last session of the intervention)

Secondary Outcomes (2)

• Change from baseline in the Modified Barthel Index for Activities of Daily Living

  (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 15th session, each session is 1 day), and (3) 4 weeks after the last session of the intervention)

• Change from baseline in the Stroke-Specific Quality of Life Scale

  (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 15th session, each session is 1 day), and (3) 4 weeks after the last session of the intervention)

Other Outcomes (1)

• Change from baseline in the Modified Ashworth Scale

  (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 15th session, each session is 1 day), and (3) 4 weeks after the last session of the intervention)

Study Arms (2)

Active stimulation group

EXPERIMENTAL

Fifteen sessions of inhibitory repetitive transcranial magnetic stimulation (rTMS) treatment at 1 Hz frequency will be applied to the contralesional primary motor cortex (hand region). The application will be performed with Neurosoft-Neuro MS / D device. 120% of the resting motor threshold will be used in the stimulation. One session of stimulation will last for a total of 30 minutes and a total of 1800 pulses in the form of 1 Hz stimulation.

Device: Repetitive transcranial magnetic stimulation

Sham stimulation group

SHAM COMPARATOR

Fifteen sessions of sham repetitive transcranial magnetic stimulation (rTMS) treatment will be applied to the contralesional primary motor cortex (hand region). The application will be performed with Neurosoft-Neuro MS / D device. The probe of the device will be held in an upright position and stimulation will be performed at the 10% of the resting motor threshold.

Device: Sham Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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.

Also known as: Neuro Soft

Active stimulation group

Sham Repetitive transcranial magnetic stimulation DEVICE

Sham Repetitive transcranial magnetic stimulation

Sham stimulation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of subcortical ischemic stroke affecting the middle cerebral artery territory, which has been confirmed by imaging methods
• Having a stroke for the first time
• Presence of subacute stroke (\< 6 months)
• Mini-mental test score ≥ 24
• Severe upper limb motor impairment (The Fugl-Meyer Assessment Scale - Upper Extremity motor impairment score ≤ 19/60, excluding reflex assessments)
• Lack of motor evoked potential (MEP) recording from the first dorsal interosseous muscle of the paretic extremity with single-pulse transcranial magnetic stimulation of the ipsilesional primary motor cortex (hand region)

You may not qualify if:

• 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
• History of psychiatric illness such as major depression/personality disorder
• History of convulsion or epilepsy or taking medication for epilepsy
• Cognitive impairment
• Pregnancy or breastfeeding
• Alcohol or drug addiction
• Previously treated with transcranial magnetic stimulation
• Moderate or mild upper extremity motor impairment (The Fugl-Meyer Assessment Scale - Upper Extremity score \> 19/60, excluding reflex assessments)
• Presence of neglect

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İlker Şengül

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (20)

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• Ko MH, Jeong YC, Seo JH, Kim YH. The after-effect of sub-threshold 10 Hz repetitive transcranial magnetic stimulation on motor cortical excitability. J Korean Acad Rehabil Med 2006;30:436-40.

  BACKGROUND

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MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• İlker Şengül, M.D.

  İzmir Katip çelebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 17, 2022
• Study Start: November 11, 2022
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)