NCT05554861

Brief Summary

The aim of our study is to investigate the effects of rTMS applications at different current frequencies (low frequency / intermittent (intermittent) theta burst (iTBS)) in stroke patients on lower extremity motor development, physical function and quality of life, and to compare the effectiveness of these modalities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

September 22, 2022

Last Update Submit

November 13, 2023

Conditions

Neurological RehabilitationStrokeLower Extremity ProblemQuality of Life

Keywords

Repetitive Transcranial Magnetic StimulationHemiplegiaNeurological Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Functional Independence Measure (FIM) at 10th day and 6th week

    Functional Independence Measure (FIM) is an approach to functional evaluation, which is widely applied, validated and reliable in Turkish society. FIM analyzes two different aspects of disability, namely motor and cognitive functions. FBO; self-care (42 points), sphincter control (14 points), transfers (21 points), locomotion (14 points), communication (14 points) and social cognition (21 points), which consists of 6 subgroups and evaluates 18 activities. . Each activity is evaluated for functional independence using a 7-point scale.

    up to 6th week

Secondary Outcomes (6)

  • Change from baseline Quality of Life (Short Form 36 (SF-36)) at 10th day and 6th week

    up to 6th week

  • Change from baseline Timed Up and Go test (TUG) at 10th day and 6th week

    up to 6th week

  • Change from baseline Fugl-Meyer Assessment Lower Extremity (FMA-LE) at 10th day and 6th week

    up to 6th week

  • Change from baseline Berg Balance Scale at 10th day and 6th week

    up to 6th week

  • Change from baseline Ratio of maximum H reflex to maximum M response (Hmax/Mmax Ratio) at 6th week

    up to 6th week

  • +1 more secondary outcomes

Study Arms (3)

Low Frequency rTMS Protocol

EXPERIMENTAL

It was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex foot area in the non-lesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions.

Device: Low Frequency rTMS Protocol

Intermittent Theta Burst Stimulation (iTBS) Protocol

ACTIVE COMPARATOR

It was planned to apply 50 Hz high-frequency stimulation protocol to the primary motor cortex foot area in the ipsilesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions.

Device: Intermittent Theta Burst Stimulation (iTBS) Protocol

Sham rTMS Protocol

PLACEBO COMPARATOR

It was planned to apply daily sham rTMS to the motor extremity area of the primary motor cortex along a 10 cm thick wood for 10 sessions.

Device: Sham rTMS Protocol

Interventions

Low Frequency rTMS ProtocolDEVICE

It was planned to apply 1 Hz low-frequency inhibition protocol to the primary motor cortex foot area in the non-lesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions. After the daily rTMS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Low Frequency rTMS Protocol
Intermittent Theta Burst Stimulation (iTBS) ProtocolDEVICE

It was planned to apply 50 Hz high-frequency stimulation protocol to the primary motor cortex foot area in the ipsilesional hemisphere, 5 days a week for 2 weeks, for a total of 10 sessions. After the daily rTBS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Intermittent Theta Burst Stimulation (iTBS) Protocol
Sham rTMS ProtocolDEVICE

It was planned to apply daily sham rTMS to the motor extremity area of the primary motor cortex along a 10 cm thick wood for 10 sessions. After the daily sham rTMS session, it was planned to apply a conventional rehabilitation therapy for 60 minutes to all patients for 6 weeks (Exercise program consisting of joint range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) for 45 minutes and 15 minutes of NMES application in the presence of an experienced physiotherapist).

Sham rTMS Protocol

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having lower extremity Brunnstrom motor stage in the 3-5 range,
  • Having had a stroke at least six months ago,
  • Being able to walk 5 meters independently with or without an assistive device,
  • Ability to follow two-stage verbal commands,
  • To agree to participate in the study voluntarily and regularly,
  • Being medically stable (without a history of myocardial infarction, without musculoskeletal problems)
  • Patients with a mini mental test of 24 and above will be accepted into our study.

You may not qualify if:

  • Severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and a significant comorbid disease such as uncontrolled hypertension,
  • Cognitive dysfunction,
  • Visual impairment,
  • Hearing problem,
  • Malignancy and active infection,
  • Skin infection in the rTMS application area,
  • Open wound,
  • Inflammatory disease,
  • Epilepsy,
  • Brain lesion or a history of drug use that will affect the seizure threshold,
  • Patients with increased intracranial pressure or uncontrolled migraine will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (3)

  • Dionisio A, Duarte IC, Patricio M, Castelo-Branco M. The Use of Repetitive Transcranial Magnetic Stimulation for Stroke Rehabilitation: A Systematic Review. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):1-31. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.008. Epub 2017 Oct 27.

    PMID: 29111342BACKGROUND

  • Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

    PMID: 31901449BACKGROUND

  • Watanabe K, Kudo Y, Sugawara E, Nakamizo T, Amari K, Takahashi K, Tanaka O, Endo M, Hayakawa Y, Johkura K. Comparative study of ipsilesional and contralesional repetitive transcranial magnetic stimulations for acute infarction. J Neurol Sci. 2018 Jan 15;384:10-14. doi: 10.1016/j.jns.2017.11.001. Epub 2017 Nov 9.

    PMID: 29249365BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Nuran EYVAZ, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

  • Ali Izzet AKÇİN, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Profesor

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 26, 2022

Study Start

September 20, 2022

Primary Completion

September 20, 2023

Study Completion

November 13, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)