- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323255
rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke (PPCstim)
Influence of the Modulation of the Posterior Parietal Cortex (rTMS) on a Pointing Movement With the Paretic Upper Limb After Stroke
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France, 59037
- Hôpital Swynghedauw, CHU lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: cTBS stimulation
continuous theta-burst TMS stimulation (1200 pulses, 50Hz, separated in two sequences of 600 pulses)
|
cTBS
|
|
Sham Comparator: SHAM stimulation (placebo)
SHAM stimulation
|
SHAM stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of movement during the pointing movement
Time Frame: 30 minutes
|
Time between the initiation of the movement and the reaching of the target
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction time (time between the go signal and th onset of the movement)
Time Frame: 30 minutes
|
temporal parameters of pointing movements
|
30 minutes
|
|
Response time (time between the go signal and the reaching of the target)
Time Frame: 30 minutes
|
temporal parameters of pointing movements
|
30 minutes
|
|
Peak velocity of the hand during the pointing movement
Time Frame: 30 minutes
|
pak velocity in m/s
|
30 minutes
|
|
smoothness (number of units of movement during the pointing movement),
Time Frame: 30 minutes
|
Spatial parameters of pointing movements
|
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)
Time Frame: 30 minutes
|
Spatial parameters of pointing movements
|
30 minutes
|
|
Detection of mirror movements with the healthy upper limb
Time Frame: 30 minutes
|
EMG detection
|
30 minutes
|
|
Primary motor cortex excitability of both motor cortices
Time Frame: 30 minutes
|
Resting motor threshold of lesioned and non-lesioned hemispheres
|
30 minutes
|
|
Parietomotor connectivity in the contralesional hemisphere
Time Frame: 30 minutes
|
Assessed by a paired-pulse TMS protocol (see Allart et al. 2017 for more details)
|
30 minutes
|
|
Spatial bias
Time Frame: 30 minutes
|
Line bisection test
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Etienne Allart, MD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016_36
- 2016-A01608-43 (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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