rTMS Posterior Parietal Cortex Modulation and Upper Limb Movement After Stroke

NCT ID: NCT03323255

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Hemiparesis Transcranial Magnetic Stimulation Brain Connectivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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cTBS stimulation

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

Group Type ACTIVE_COMPARATOR

repeated transcranial magnetic stimulation continuous theta-burst stimulation

Intervention Type DEVICE

cTBS

SHAM stimulation (placebo)

SHAM stimulation

Group Type SHAM_COMPARATOR

SHAM repeated transcranial magnetic stimulation

Intervention Type DEVICE

SHAM stimulation

Interventions

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repeated transcranial magnetic stimulation continuous theta-burst stimulation

cTBS

Intervention Type DEVICE

SHAM repeated transcranial magnetic stimulation

SHAM stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etienne Allart, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Swynghedauw, CHU lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Etienne Allart, MD

Role: CONTACT

3 20 44 48 71 ext. +33

Facility Contacts

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Role: primary

0320445962

Other Identifiers

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2016-A01608-43

Identifier Type: OTHER

Identifier Source: secondary_id

2016_36

Identifier Type: -

Identifier Source: org_study_id

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