NCT04816305

Brief Summary

This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 22, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

October 22, 2020

Last Update Submit

May 8, 2023

Conditions

Stroke

Keywords

Transcranial magnetic stimulationElectroencephalogramPhysiotherapyBrain symmetryBiomarker

Outcome Measures

Primary Outcomes (4)

  • Brain symmetry (baseline)

    Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (\> 4 a ≤ 8 Hz); alpha (\> 8 a ≤13 Hz); beta (\> 13 a ≤ 30 Hz); gama (\< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.

    Before each session (10 sessions for 5 days a week for two weeks)

  • Brain symmetry (post-treatment)

    Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (\> 4 a ≤ 8 Hz); alpha (\> 8 a ≤13 Hz); beta (\> 13 a ≤ 30 Hz); gama (\< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.

    After each session (10 sessions for 5 days a week for two weeks)

  • Brain symmetry (baseline)

    Accessed with: Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.

    Before each session (10 sessions for 5 days a week for two weeks)

  • Brain symmetry (post-treatment)

    Accessed with: Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.

    After each session (10 sessions for 5 days a week for two weeks)

Secondary Outcomes (3)

  • Change in Fugl Meyer assesment of paretic upper limb motor function

    10 sessions (5 days a week for two weeks)

  • Modified Ashworth Scale

    10 sessions (5 days a week for two weeks)

  • The National Institutes of Health Stroke

    10 sessions (5 days a week for two weeks)

Study Arms (3)

rTMSc + physiotherapy

EXPERIMENTAL

A conventional high-frequency rTMS (rTMSc) will be applied over the lesioned hemisphere over the motor cortex. After rTMSc, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.

Device: rTMScBehavioral: Neurofunctional physiotherapy

rTMSp + physiotherapy

EXPERIMENTAL

A personalized high or low-frequency rTMS (rTMSp) will be applied to the lesioned or non-lesioned hemisphere depending on cortical biomarkers assessment guide a personalized stimulation for each patient in this group. After rTMSp, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.

Device: rTMScBehavioral: Neurofunctional physiotherapy

tDCS sham + physiotherapy

SHAM COMPARATOR

The sham protocol will be delivered to each patient of this arm imitating the exat sound of the equipment and structure of the experimental arms. After rTMS sham, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.

Behavioral: Neurofunctional physiotherapyDevice: rTMS sham

Interventions

rTMScDEVICE

In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.

rTMSc + physiotherapyrTMSp + physiotherapy
Neurofunctional physiotherapyBEHAVIORAL

All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.

rTMSc + physiotherapyrTMSp + physiotherapytDCS sham + physiotherapy
rTMS shamDEVICE

During the rTMS sham sessions the same procedures will be used as the rTMSc protocols, however, the magnetic stimulator and its coil will be turned off.

tDCS sham + physiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 3 months after stroke;
  • Ischemic or hemorrhagic stroke with upper limb motor impairment;

You may not qualify if:

  • Any contraindication for application of transcranial magnetic stimulation;
  • Peripheral lesions in the assessed upper limb;
  • Score ≤ 18 at Folstein Mini Mental State Examination;
  • Alteration of drugs that alter the excitability of the cortex (in less than 3 months);
  • Application of botulinum toxin in less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pernambucano

Recife, Pernambuco, 50740-560, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Kátia Karina Monte-Silva, PhD

CONTACT

+558121267579monte.silvakk@gmail.com

Gabriel Barreto Antonino

CONTACT

+5583996106134gabrielbarreto@live.com

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
Clinical professor

Study Record Dates

First Submitted

October 22, 2020

First Posted

March 25, 2021

Study Start

March 29, 2021

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

BR(1)