Using Repetitive Transcranial Magnetic Stimulation (rTMS) in the Rehabilitation of Chronic Spatial Neglect After Stroke

NCT01000103 | Completed Phase 3

• 2 other identifiers: P071238ID RCB 2009-A00280-57
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 space, impairing functional rehabilitation and adaptation back to a normal life. The primary purpose of this protocol is to assess the impact of 10 daily sessions of a non-invasive brain stimulation technique, low frequency repetitive Transcranial Magnetic Stimulation (rTMS), applied on the intact hemisphere of the brain to treat post stroke visuospatial neglect at the chronic stage. The hypothesis is that a regime of real but not sham rTMS on the left posterior parietal cortex of the brain will long-lastingly ameliorate visuospatial neglect in stroke patients as revealed by clinical paper-and-pencil and computer-based tests assessing search, detection and discrimination of stimuli presented in different areas of the visual field.

Conditions

Cerebrovascular Disorders; Cerebral Stroke; VISIO-spatial Neglect; VISUO-spatial Extinction

Keywords

Stroke; Visuospatial neglect; Visuospatial extinction; Transcranial Magnetic Stimulation (TMS); Non-invasive brain stimulation; Neuromodulation; Brain parietal cortex; Neurological sequels; Cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes in the Spatial Bias Compound Score (SBCS). Such score is calculated on the basis of the result of 4 subtests

  between pre (baseline) and post 10 days of rTMS treatment

Secondary Outcomes (12)

• Changes in Catherine BERGEGO Scale and-or equivalent ecological test

  between pre (baseline) and every subsequent evaluation

• Changes in the percentage of correct target detections vs. total

  between pre (baseline) and every subsequent evaluation

• Changes in the Normalized reaction time of correct detections

  between pre (baseline) and every subsequent evaluation

• potential clinically relevant side-effect caused by the use of TMS in terms of neurological manifestations such as: seizure, occurrence of additional stroke, or signs of enhanced intracranial pressure.

  During rTMS treatment and the 6 months follow-up

• changes in cognitive functions processed by the intact left parietal cortex

  between baseline and every subsequent evaluation, during the 6 months follow-up

Study Arms (2)

1: Real rTMS treatment

ACTIVE COMPARATOR

Transcranial Magnetic Stimulation, in a low frequency (1 Hz) continuous train of 20 minutes (1200 pulses)

Device: Real rTMS

2: Sham rTMS treatment

SHAM COMPARATOR

Simulation of rTMS

Device: Sham rTMS

Interventions

Real rTMS DEVICE

Transcranial Magnetic Stimulation, in a low frequency (1 Hz) continuous train of 20 minutes (1200 pulses)

1: Real rTMS treatment

Sham rTMS DEVICE

two TMS coils will be used: a passive one which is placed flat on top of the "actively" targeted region which remains unplugged and generates a continuous scalp tactile sensation, and an active one located at a prudential distance from the scalp, which will deliver active pulses and its accompanying sensations

2: Sham rTMS treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital de la Salpétrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pascale PRADAT-DIEHL, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Antoni VALERO-CABRE, MD-PhD

  Centre National de la Recherche Scientifique, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: March 24, 2010
• Primary Completion: October 15, 2014
• Study Completion: October 15, 2014
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

FR (1)