NCT03323255

Brief Summary

This study evaluates the effect of a unique session of inhibitory rTMS (cTBS) over the contralesional posterio parietal cortex (PPC) on the spatio-temporal parameters of a pointing movement performed by stroke patients with their paretic upper limb. It will also assess the effects on the resting motor threshold of both hemispheres and on parietopremotor connectivity. To achieve theses aims, the real cTBS stimulation will be randomly counterbalanced with a SHAM stimulation (in a second session) in a crossover design. Assessments will be performed before and after each stimulation session.

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 stroke

Timeline
Completed

Started Mar 2020

Shorter than P25 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 16, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

October 16, 2017

Last Update Submit

March 25, 2020

Conditions

StrokeHemiparesisTranscranial Magnetic StimulationBrain Connectivity

Outcome Measures

Primary Outcomes (1)

  • Time of movement during the pointing movement

    Time between the initiation of the movement and the reaching of the target

    30 minutes

Secondary Outcomes (9)

  • Reaction time (time between the go signal and th onset of the movement)

    30 minutes

  • Response time (time between the go signal and the reaching of the target)

    30 minutes

  • Peak velocity of the hand during the pointing movement

    30 minutes

  • smoothness (number of units of movement during the pointing movement),

    30 minutes

  • Linearity (ration between the length of the trajectory of the hand and the linear distance between the initial position of the hand and the target)

    30 minutes

  • +4 more secondary outcomes

Study Arms (2)

cTBS stimulation

ACTIVE COMPARATOR

continuous theta-burst TMS stimulation (1200 pulses, 50Hz, separated in two sequences of 600 pulses)

Device: repeated transcranial magnetic stimulation continuous theta-burst stimulation

SHAM stimulation (placebo)

SHAM COMPARATOR

SHAM stimulation

Device: SHAM repeated transcranial magnetic stimulation

Interventions

repeated transcranial magnetic stimulation continuous theta-burst stimulationDEVICE

cTBS

cTBS stimulation
SHAM repeated transcranial magnetic stimulationDEVICE

SHAM stimulation

SHAM stimulation (placebo)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80y
  • Right-handed
  • Right hemispheric stroke confirmed by a 3D imaging technique
  • at the chronic phase (\>6months)
  • subject being able to perform a pointing movement of at least 20cm in the anterior space without compensatory movements of the trunk
  • informed consent
  • Social security affiliation

You may not qualify if:

  • Severe comprehension troubles (language, cognitive or psychiatric disorders)
  • History of neurological disorders in addition to the stroke
  • Locomotor troubles affecting the paretic arm
  • Contraindication to rTMS : epilepsy, intracranial metallic foreign body, cochlear implant, unstable fracture of the skull bones, deafness
  • pregnancy or breastfeeding
  • adult subject to guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Swynghedauw, CHU lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Etienne Allart, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne Allart, MD

CONTACT

3 20 44 48 71etienne.allart@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 26, 2017

Study Start

March 10, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)