rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke

Stroke Clinical Trial

— PPCstim  

Official title:

Influence of the Modulation of the Posterior Parietal Cortex (rTMS) on a Pointing Movement With the Paretic Upper Limb After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323255
• Other study ID #: 2016_36
• Secondary ID: 2016-A01608-43
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: August 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: Etienne Allart, MD
• Phone: 3 20 44 48 71
• Email: etienne.allart[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Connectivity
• Hemiparesis
• Paresis
• Stroke
• Transcranial Magnetic Stimulation

Intervention

Device:
• repeated transcranial magnetic stimulation continuous theta-burst stimulation
cTBS
• SHAM repeated transcranial magnetic stimulation
SHAM stimulation

Locations

Country	Name	City	State
France	Hôpital Swynghedauw, CHU lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of movement during the pointing movement	Time between the initiation of the movement and the reaching of the target	30 minutes
Secondary	Reaction time (time between the go signal and th onset of the movement)	temporal parameters of pointing movements	30 minutes
Secondary	Response time (time between the go signal and the reaching of the target)	temporal parameters of pointing movements	30 minutes
Secondary	Peak velocity of the hand during the pointing movement	pak velocity in m/s	30 minutes
Secondary	smoothness (number of units of movement during the pointing movement),	Spatial parameters of pointing movements	30 minutes
Secondary	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)	Spatial parameters of pointing movements	30 minutes
Secondary	Detection of mirror movements with the healthy upper limb	EMG detection	30 minutes
Secondary	Primary motor cortex excitability of both motor cortices	Resting motor threshold of lesioned and non-lesioned hemispheres	30 minutes
Secondary	Parietomotor connectivity in the contralesional hemisphere	Assessed by a paired-pulse TMS protocol (see Allart et al. 2017 for more details)	30 minutes
Secondary	Spatial bias	Line bisection test	30 minutes