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Effects of rTMS on Brain Alterations in Stroke Patients

5 augusti 2019 uppdaterad av: Yating Lv, PhD, Hangzhou Normal University

Effects of Different Frequency rTMS on Brain Functional and Structural Alterations in Stroke Patient: Multi-modal MRI Study

In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.

The patients will be randomized into three groups: Experimental group 1 (TMS group) received low frequency rTMS; Experimental group 2 (TMS group) received high frequency rTMS; The third group who received only physical therapy constituted the control group. All patients undergo MRI scan one day before and after rTMS treatment.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

As the second leading cause of death and major cause of disability in the world, stroke is the rapid loss of brain function due to disturbance in the blood supply to the brain. Approximately two thirds of patients with stroke have impaired motor function even at three to six months after stroke onset. The abnormally increased interhemispheric inhibition driven from the unaffected to the affected hemisphere is associated with the motor impairment, which is characterized by increased cortical excitability in the unaffected hemisphere and decreased cortical excitability in the affected hemisphere. Rebalancing the cortical excitability between two hemispheres is associated with a better overall prognosis.

Repetitive transcranial magnetic stimulation (rTMS) is a painless, noninvasive brain stimulation technique. High-frequency rTMS facilitates cortical excitability, whereas low-frequency rTMS decreases the cortical excitability of the stimulated hemisphere. Therefore, rTMS can be used to increase and decrease the cortical excitability of the affected and unaffected hemispheres, respectively, and may facilitate motor function after stroke. However, the previous studies commonly applied behavioral scales to evaluate the effect of the rTMS treatment, little is known how the brain function and structure recover after rTMS treatment and whether the different frequency of rTMS will affect the recovery in the brain of stroke patients.

Non-invasive neuroimaging techniques provide promising avenues to detect brain function and structure in patients after stroke onset and have been increasingly applied to this disease. The morphology of the brain (cortical thickness, gray matter volume) is commonly assessed using T1-weighted MRI (Structural MRI). Diffusion tensor imaging (DTI) is a promising technique to study human brain structure, especially white matter anatomy, by providing multiple quantitative parameters to characterize tissue microstructure from different aspects. Functional magnetic resonance imaging (fMRI) is a functional neuroimaging technique which measures the changes of the blood oxygenation level-dependent (BOLD) signal that are highly correlated with neural activities. Task fMRI which applies stimulus-response pattern to identify the regions activated by performance of a cognitive task, while resting-state fMRI (rs-fMRI) is a promising tool to map intrinsic function of the human brain, which has unique advantages in clinical conditions because it does not require participants to engage in cognitive activities.

In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in stroke patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.

Studietyp

Interventionell

Inskrivning (Förväntat)

10

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Lingyu Li, Bachelor
  • Telefonnummer: +86-15990149749
  • E-post: llyxl621@126.com

Studieorter

    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210000
        • Rekrytering
        • Affiliated Hospital of Nanjing University of Chinese Medicine
        • Kontakt:
          • Haiyang Fu, Master
          • Telefonnummer: +86-13851905128
          • E-post: fhy112@sina.com
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 311121
        • Aktiv, inte rekryterande
        • Hangzhou Normal University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. First-ever ischemic stroke
  2. One to six months after stroke onset;
  3. Mini Mental State Examination (MMSE) score > 24;
  4. Brunnstrom recovery stage (BRS) for hand fingers of 3-5
  5. Motor deficits of the unilateral upper limb

Exclusion Criteria:

Patients with hemorrhage, leukoaraiosis, epilepsy, migraine or psychiatric diseases history are excluded in this study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Low frequency rTMS
Patients receive low frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the unaffected side for two weeks, 5 consecutive days each week.
Receive rTMS treatment to the primary motor cortex (M1)
Receive physical therapy
Experimentell: High frequency rTMS
Patients receive high frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the affected side for two weeks, 5 consecutive days each week.
Receive rTMS treatment to the primary motor cortex (M1)
Receive physical therapy
Aktiv komparator: Physical therapy
Patients receive physical therapy for two weeks.
Receive physical therapy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Brain functional changes after rTMS treatment
Tidsram: One day before and after two weeks' treatment
Brain functional changes in patients' brain measured by fMRI
One day before and after two weeks' treatment
Brain morphological changes after rTMS treatment
Tidsram: One day before and after two weeks' treatment
Gray matter morphological changes in patients' brain measured by high resolution T1-weighted MRI
One day before and after two weeks' treatment
Brain structural changes after rTMS treatment
Tidsram: One day before and after two weeks' treatment
White matter anatomical changes in patients' brain measured by DTI
One day before and after two weeks' treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Yu-Feng Zang, MD, Hangzhou Normal University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2018

Primärt slutförande (Förväntat)

31 december 2020

Avslutad studie (Förväntat)

31 december 2020

Studieregistreringsdatum

Först inskickad

19 april 2018

Först inskickad som uppfyllde QC-kriterierna

7 maj 2018

Första postat (Faktisk)

18 maj 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

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Kliniska prövningar på rTMS

3
Prenumerera