NCT03627364

Brief Summary

Healthy individuals, after reading and signing the free and informed consent will be submitted to a single session to obtain the normal neurophysiological measures and thus compare with those obtained in individuals with PD. Healthy and post stroke patients will be submitted to a neurophysiological evaluation through transcranial magnetic stimulation (TMS) and electroencephalography (EEG). The post stroke patients will also performed the evaluation trought the fugl meyer scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

August 8, 2018

Last Update Submit

May 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensory-motor recovery level

    Fugl Meyer assesment of paretic upper limb motor function is used to measure motor control recovery. It is a 226 point scoring system that includes the following sessions: range of motion, pain, sensation,motor function of upper and lower limbs, balance, coordination and velocity. We will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points

    baseline

Secondary Outcomes (2)

  • Cortical excitabilit level

    baseline

  • level of cortical electrical activity

    baseline

Study Arms (2)

Post stroke patients

will be submitted to a single session to obtain the normal neurophysiological and behavioral endpoints and thus compare with those obtained in healthy individuals.

Control group

will be submitted to a single session to obtain the normal neurophysiological and behavioral endpoints and thus compare with those obtained in post stroke patients.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population study was composite for patients post-stroke with auditory major that 3 months and found in the eligibility criteria. In addition, it will rely on babies with health or neurological disorders.

You may qualify if:

  • Post stroke patients
  • Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging
  • Chronic Stroke (\> 3 months)
  • Sensorimotor sequelae in an upper limb due to stroke
  • Score ≥ 18 at Folstein Mini Mental State Examination Healthy Subjects
  • Ages: 40 years or greater
  • Gender: Both
  • Subjects who do not have self-report of neurological or articular disorder

You may not qualify if:

  • Post stroke patients
  • Prior neurological diseases
  • Multiple brain lesions
  • Metal implant in the skull and face
  • Pacemaker
  • History of seizures
  • Epilepsy
  • Pregnancy
  • Hemodynamic instability
  • Traumatic orthopedic injuries of upper limb that compromise the function
  • Altered medication for less than 3 months or who underwent botulinum toxin for less than 6 months
  • Performing physical therapy elsewhere during the period of intervention Healthy Subjects
  • Pregnant women;
  • Pacemaker;
  • History of seizures;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-900, Brazil

Location

Applied Neuroscience Laboratory

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 13, 2018

Study Start

August 15, 2018

Primary Completion

December 20, 2018

Study Completion

March 3, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations