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Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation (PRIStiM1)

Primary Purpose

Neurologic Neglect Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Control: placebo stimulation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurologic Neglect Syndrome focused on measuring Neurologic neglect syndrome, post stroke, transcranial direct current stimulation (tDCS), prismatic adaptation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Right-handed
  • All subjects must be between the ages of 18-80
  • Patient with unilateral negligence consecutive to a right hemispheric stroke
  • Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week) or external monitoring
  • Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a radiological report
  • Diagnosis of negligence evidenced by Behavioural Inattention Test (BIT) : score ≤ 129
  • Stroke >1 month prior to study enrollment

Exclusion Criteria:

  • Degenerative neurological complaint
  • Uncontrolled epilepsy
  • Temporo-spatial disorientation
  • Language disorders or psychiatric disorders preventing understanding instructions
  • History of prior stroke, multiple stroke
  • Medical condition not stabilized
  • Pregnancy
  • Implanted material (pacemaker, defibrillator, cochlear implant, surgical clips, metal object)
  • Intra-cranial material
  • Unweaned alcoholism

Sites / Locations

  • Hôpital henri Gabriel (Hospices Civils de Lyon)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A Anodal tDCS and prismatic adaptation

Arm B: control

Arm Description

anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).

Prismatic adaptation with placebo stimulation

Outcomes

Primary Outcome Measures

Behavioural Inattention Test (BIT)
assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion.

Secondary Outcome Measures

Negligence Battery Test (BTN)
Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Functional independence scale (MIF)
Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Catherine Bergego scale (ECB)
Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Jamar
Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions

Full Information

First Posted
August 8, 2014
Last Updated
August 13, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02213640
Brief Title
Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
Acronym
PRIStiM1
Official Title
Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 26, 2014 (Actual)
Primary Completion Date
May 25, 2018 (Actual)
Study Completion Date
May 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term. Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term. Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Neglect Syndrome
Keywords
Neurologic neglect syndrome, post stroke, transcranial direct current stimulation (tDCS), prismatic adaptation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A Anodal tDCS and prismatic adaptation
Arm Type
Experimental
Arm Description
anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
Arm Title
Arm B: control
Arm Type
Placebo Comparator
Arm Description
Prismatic adaptation with placebo stimulation
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
Intervention Type
Device
Intervention Name(s)
Control: placebo stimulation
Intervention Description
electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).
Primary Outcome Measure Information:
Title
Behavioural Inattention Test (BIT)
Description
assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion.
Time Frame
Change in BIT score between the baseline sessions average and score measured at week 11
Secondary Outcome Measure Information:
Title
Negligence Battery Test (BTN)
Description
Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Time Frame
before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Title
Functional independence scale (MIF)
Description
Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Time Frame
before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Title
Catherine Bergego scale (ECB)
Description
Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Time Frame
baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Title
Jamar
Description
Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Time Frame
baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Right-handed All subjects must be between the ages of 18-80 Patient with unilateral negligence consecutive to a right hemispheric stroke Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week) or external monitoring Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a radiological report Diagnosis of negligence evidenced by Behavioural Inattention Test (BIT) : score ≤ 129 Stroke >1 month prior to study enrollment Exclusion Criteria: Degenerative neurological complaint Uncontrolled epilepsy Temporo-spatial disorientation Language disorders or psychiatric disorders preventing understanding instructions History of prior stroke, multiple stroke Medical condition not stabilized Pregnancy Implanted material (pacemaker, defibrillator, cochlear implant, surgical clips, metal object) Intra-cranial material Unweaned alcoholism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN-COURTOIS, MD-PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital henri Gabriel (Hospices Civils de Lyon)
City
Saint-Genis Laval
ZIP/Postal Code
69230
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34196963
Citation
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Results Reference
derived
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

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Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation

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