Status:
COMPLETED
Using Repetitive Transcranial Magnetic Stimulation (rTMS) in the Rehabilitation of Chronic Spatial Neglect After Stroke
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cerebrovascular Disorders
Cerebral Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Visuospatial neglect is a common neurological symptom which appears following strokes on regions of the right hemisphere of the brain. It affects patient's self representation and awareness of the spa...
Detailed Description
Scientific aims and goals: The long-term goal aim of this application is to provide evidence of the role of a non-invasive neuromodulation technique such as rTMS in the treatment of chronic neurologi...
Eligibility Criteria
Inclusion
- Unilateral right hemisphere stroke
- Visuospatial neglect or extinction at the time of entry, as determined by at least 1 test of the battery (BEN) displaying pathological scores (cut off values as defined in AZOUVI et al. JNNP 2004, Table 1), or an ECB test, score \> 8
- A period of evolution of at least 3 months since stroke event
- Age between 18 and 75 years old
- Affiliation to Social Security system
- Informed consent signature
Exclusion
- Criteria related to the stroke:
- Bilateral stroke lesions: left hemispheric focal lesion excluding leucoaraiosis or mild lesions of the white matter
- Criteria related to rTMS:
- Metal in the head, or a history of prior neurosurgical procedures
- Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic means such as: cochlear implants, pacemakers, medication pumps, vagal stimulators, deep brain stimulators, neurostimulators, bio stimulators, or ventriculoperitoneal shunts.
- Prior history of seizures or seizure events following the stroke requiring the use of antiepileptic drugs
- Pregnancy (by history or positive urine pregnancy test)
- A urine pregnancy test will be done on all women of childbearing potential (those who have started menstruating up until they have stopped menstruating) prior to each MRI session, to rule out pregnancy.
- Diagnosis of tinnitus
- Participation in any experimental neglect rehabilitation project for at least 5 weeks before and 2 weeks after the stimulation, or during the 6 months of follow-up.
- Prior participation in TMS based treatments or experiments
- Criteria related to feasibility:
- Incapacity to follow and complete the stimulation and follow-up protocol
- Other medical cerebral conditions other than the condition studied in the present protocol
- Any general medical condition, which could potentially interfere with clinical progression
- Any incapacitating psychiatric conditions, including significant history of substance abuse and severe depression
- Chronic treatment with medications that might modify cortical excitability
- Subjects with visual impediments that would limit our ability to obtain reliable testing
Key Trial Info
Start Date :
March 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01000103
Start Date
March 24 2010
End Date
October 15 2014
Last Update
February 25 2021
Active Locations (1)
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1
Hôpital de la Salpétrière
Paris, France, 75013