The Effect of Low-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Stroke Patients

NCT06889922 | Completed

• 1 other identifier: AnkaraCHBilkent-PMR-Ozdogan
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we aimed to demonstrate the effects of 1 Hz rTMS applied to the contralesional hemisphere on upper extremity spasticity, spinal excitability, and additionally on motor recovery in stroke patients in the chronic phase with clinically and electrophysiological parameters (Hmax/Mmax).

Conditions

Spasticity, Post-Stroke

Keywords

Transcranial Magnetic Stimulation; Spasticity; Functional Recovery

Outcome Measures

Primary Outcomes (2)

• Modified Ashworth Scale (MAS)

  The Modified Ashworth Scale (MAS) is an updated version of the original Ashworth Scale, designed to assess spasticity in patients with central nervous system disease. It measures the increase in muscle tone, assigning a spasticity grade on a 0-4 ordinal scale. 0: no increase in muscle tone, 1: minimal resistance at the end of the range of motion, 1+: slight increase in muscle tone less than half of the ROM, 2: increase in muscle tone through most of the ROM, 3: considerable increase in muscle tone, passive movement difficult, 4: affected parts rigid.

  Baseline (before treatment), 2nd week (at the end of treatment), 6th week

• Electromyography - H-reflex (Hmax/Mmax)

  The H reflex is the electrophysiological analogue of the stretch reflex. An increase in the amplitude of the H reflex is an indicator of spinal excitability. The peak-to-peak amplitude of the highest H reflex obtained from the flexor carpi radialis muscle (Hmax) is expressed as the ratio of the peak-to-peak amplitude of the maximum M response (Mmax) to Hmax (Hmax/Mmax). A higher Hmax/Mmax ratio obtained from the flexor carpi radialis muscle indicates reduced voluntary motor activity and increased reflex excitability.

  Baseline (before treatment), 2nd week (at the end of treatment), 6th week

Secondary Outcomes (1)

• Fugl-Meyer Upper Extremity Motor Assessment Scale

  Baseline (before treatment), 2nd week (at the end of treatment), 6th week

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Patients received a total of 10 sessions active rTMS on M1 region of the non-lesional hemisphere. TMS coil was initially placed tangentially to the scalp over the presumed motor cortex area. The motor hotspot is defined as the location where the lowest stimulus intensity consistently produces a significant motor-evoked potentials (MEP) in the first dorsal interosseous muscle. Once the hotspot was identified, the resting motor threshold (rMT) was determined as the lowest single pulse TMS intensity required to produce a MEP amplitude larger than 50 mV in more than 5 out of 10 trials from the first dorsal interosseous muscle. 1200 pulses at 90% of the rMT were delivered to the hotspot of the first dorsal interosseous muscle in the contralesional hemisphere. A routine physical therapy and rehabilitation program, including range of motion exercises for the upper extremity, neurophysiological exercises, and occupational therapy, was applied to patients within 30 min after TMS sessions.

Device: Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Patients received a total of 10 sessions sham rTMS on M1 region of the non-lesional hemisphere. However, a sham coil was used for stimulation, thus no actual stimulation was administered to the patients. Instead, the sham coil produced a sensation resembling real stimulation, with sounds and sensations on the scalp that simulated the feeling of active stimulation. A routine physical therapy and rehabilitation program, including range of motion exercises for the upper extremity, neurophysiological exercises, and occupational therapy, was applied to patients within 30 min after TMS sessions.

Device: Transcranial Magnetic Stimulation Sham

Interventions

Transcranial Magnetic Stimulation DEVICE

Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Coil

Active rTMS

Transcranial Magnetic Stimulation Sham DEVICE

Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Sham Coil

Sham rTMS

Eligibility Criteria

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

You may qualify if:

• Having a lesion in a single hemisphere confirmed by MRI,
• At least 6 months and at most 2 years having passed since the stroke,
• Spasticity in wrist flexors and finger flexors at levels 1+, 2, or 3 according to the modified Ashworth scale,
• Being between 18-75 years old,
• Having a Mini-Mental Test score of ≥ 24,
• If using antispastic medication, no change in medication dosage in the last month.

You may not qualify if:

• History of epilepsy, dementia, cognitive impairment, or neurodegenerative disease,
• Having a metallic materials in the area to be stimulated (such as a cochlear implant, brain pacemaker, or drug pump),
• Alcoholism,
• Pregnancy,
• Severe and newly decompensated heart failure,
• Using medications that lower the seizure threshold.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Elif Yalçın, Prof, MD

  Ankara City Hospital Bilkent

  STUDY CHAIR

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: MD, Principal Investigator

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: July 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: March 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)