NCT03481179

Brief Summary

In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

February 1, 2018

Last Update Submit

March 21, 2018

Conditions

Chronic Stroke

Keywords

Repetitive transcranial magnetic stimulation, Physiotherapy, Stroke, Spasticity

Outcome Measures

Primary Outcomes (1)

  • Spasticity

    Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.

    before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days

Secondary Outcomes (7)

  • Cortical excitability

    before and after 10 daily sessions and after 30 days

  • Variation of the median nerve Hmax / Mmax ratio

    before and after 10 sessions and after 30 days

  • Sensory-motor function of the upper limb

    before and after 10 daily sessions and after 30 days

  • Quality of life

    before and after 10 daily sessions and after 30 days

  • Qualitative and quantitative of moviment

    before and after 10 daily sessions and after 30 days

  • +2 more secondary outcomes

Study Arms (2)

Experimental: hf rTMS and Physical therapy

EXPERIMENTAL

High frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol.

Device: TMSOther: Physical therapy

Control: Sham hf rTMS and Physical theraphy

SHAM COMPARATOR

In this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol.

Device: TMSOther: Physical therapy

Interventions

TMSDEVICE

Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause some discomfort with a mild headache sensation or nausea. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing spasticity inhibition. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.

Also known as: non invasive brain stimulation, high frequency rTMS
Control: Sham hf rTMS and Physical theraphyExperimental: hf rTMS and Physical therapy
Physical therapyOTHER

The physical therapy, with an duration of 40-50 minutes, will be focused on the upper limbs and will be based on the principles of neuroplasticity (repetition, intensity, specificity, among others (KLEIM \& JONES, 2008), with a protocol that will cover different exercises and degrees of difficulty, which will be chosen according to the need and capacity of each patient

Control: Sham hf rTMS and Physical theraphyExperimental: hf rTMS and Physical therapy

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30 to 75 years;
  • Both sexes;
  • With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
  • Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON \& SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
  • With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)

You may not qualify if:

  • Contraindications to and EMT (ROSSINI et al., 2015)
  • Clinical evidence of multiple brain lesions
  • Trauma-orthopedic injury that limits the range of motion of the upper limb
  • Presence of visual and / or communication deficit
  • Involvement of other interventions focused on reducing spasticity
  • Modification of medications in the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50740-560, Brazil

RECRUITING

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Kátia Monte-Silva, PhD

    Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

    STUDY DIRECTOR

Central Study Contacts

Kátia Monte-Silva, PhD

CONTACT

+55 81 988631322monte.silvakk@gmail.com

Camilla Sales, PT

CONTACT

+55 81 997299255millbasales@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 1, 2018

First Posted

March 29, 2018

Study Start

August 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2019

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

BR(1)