NCT02201927

Brief Summary

Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

July 22, 2014

Last Update Submit

February 2, 2015

Conditions

Keywords

galvanic vestibular stimulationright parietal lobe lesionegocentric space

Outcome Measures

Primary Outcomes (1)

  • deviation from target score

    difference in degree between the actual and target score

    30 min

Secondary Outcomes (2)

  • deviation from target "straight ahead"

    30min

  • deviation rightward line bisection

    30min

Study Arms (3)

patient with right parietal lobe lesion

EXPERIMENTAL

Patient with right parietal lobe lesion

Device: galvanic vestibular stimulation

patient stroke

EXPERIMENTAL

patient with cerebral vascular accident

Device: galvanic vestibular stimulation

healthy volunteers

EXPERIMENTAL

healthy volunteers

Device: galvanic vestibular stimulation

Interventions

Also known as: deviation from target score with and without galvanic vestibular stimulation
healthy volunteerspatient strokepatient with right parietal lobe lesion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with right posterieur parietal lobe lesion
  • patient with cerebral vascular stroke
  • healthy volonteers Age greater than or equal to 18 written informed consent

You may not qualify if:

  • patient's refusal to participate to the study
  • inability to cooperate
  • cognitive trouble
  • epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare Mpr

Garches, Garches, 92380, France

Location

Study Officials

  • Ruet Alexis, PHD

    HOPITAL RAYMOND POINCARE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 28, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations