rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke (PPCstim)
Primary Purpose
Stroke, Hemiparesis, Transcranial Magnetic Stimulation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
repeated transcranial magnetic stimulation continuous theta-burst stimulation
SHAM repeated transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Hôpital Swynghedauw, CHU lilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
cTBS stimulation
SHAM stimulation (placebo)
Arm Description
continuous theta-burst TMS stimulation (1200 pulses, 50Hz, separated in two sequences of 600 pulses)
SHAM stimulation
Outcomes
Primary Outcome Measures
Time of movement during the pointing movement
Time between the initiation of the movement and the reaching of the target
Secondary Outcome Measures
Reaction time (time between the go signal and th onset of the movement)
temporal parameters of pointing movements
Response time (time between the go signal and the reaching of the target)
temporal parameters of pointing movements
Peak velocity of the hand during the pointing movement
pak velocity in m/s
smoothness (number of units of movement during the pointing movement),
Spatial parameters of pointing movements
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
Detection of mirror movements with the healthy upper limb
EMG detection
Primary motor cortex excitability of both motor cortices
Resting motor threshold of lesioned and non-lesioned hemispheres
Parietomotor connectivity in the contralesional hemisphere
Assessed by a paired-pulse TMS protocol (see Allart et al. 2017 for more details)
Spatial bias
Line bisection test
Full Information
NCT ID
NCT03323255
First Posted
October 16, 2017
Last Updated
March 25, 2020
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03323255
Brief Title
rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke
Acronym
PPCstim
Official Title
Influence of the Modulation of the Posterior Parietal Cortex (rTMS) on a Pointing Movement With the Paretic Upper Limb After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Transcranial Magnetic Stimulation, Brain Connectivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cTBS stimulation
Arm Type
Active Comparator
Arm Description
continuous theta-burst TMS stimulation (1200 pulses, 50Hz, separated in two sequences of 600 pulses)
Arm Title
SHAM stimulation (placebo)
Arm Type
Sham Comparator
Arm Description
SHAM stimulation
Intervention Type
Device
Intervention Name(s)
repeated transcranial magnetic stimulation continuous theta-burst stimulation
Intervention Description
cTBS
Intervention Type
Device
Intervention Name(s)
SHAM repeated transcranial magnetic stimulation
Intervention Description
SHAM stimulation
Primary Outcome Measure Information:
Title
Time of movement during the pointing movement
Description
Time between the initiation of the movement and the reaching of the target
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Reaction time (time between the go signal and th onset of the movement)
Description
temporal parameters of pointing movements
Time Frame
30 minutes
Title
Response time (time between the go signal and the reaching of the target)
Description
temporal parameters of pointing movements
Time Frame
30 minutes
Title
Peak velocity of the hand during the pointing movement
Description
pak velocity in m/s
Time Frame
30 minutes
Title
smoothness (number of units of movement during the pointing movement),
Description
Spatial parameters of pointing movements
Time Frame
30 minutes
Title
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)
Description
Spatial parameters of pointing movements
Time Frame
30 minutes
Title
Detection of mirror movements with the healthy upper limb
Description
EMG detection
Time Frame
30 minutes
Title
Primary motor cortex excitability of both motor cortices
Description
Resting motor threshold of lesioned and non-lesioned hemispheres
Time Frame
30 minutes
Title
Parietomotor connectivity in the contralesional hemisphere
Description
Assessed by a paired-pulse TMS protocol (see Allart et al. 2017 for more details)
Time Frame
30 minutes
Title
Spatial bias
Description
Line bisection test
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Etienne Allart, MD
Phone
3 20 44 48 71
Ext
+33
Email
etienne.allart@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne Allart, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Swynghedauw, CHU lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
First Name & Middle Initial & Last Name & Degree
Etienne Allart, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke
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