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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)

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ClinicalTrials.gov Identifier: NCT02213640
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Neurologic Neglect Syndrome Device: transcranial direct current stimulation (tDCS) Device: Control: placebo stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
Actual Study Start Date : December 26, 2014
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Arm A Anodal tDCS and prismatic adaptation
anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
Device: transcranial direct current stimulation (tDCS)
Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).

Placebo Comparator: Arm B: control
Prismatic adaptation with placebo stimulation
Device: Control: placebo stimulation
electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).




Primary Outcome Measures :
  1. Behavioural Inattention Test (BIT) [ Time Frame: Change in BIT score between the baseline sessions average and score measured at week 11 ]
    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 :
  1. Negligence Battery Test (BTN) [ 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) ]
    Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions

  2. Functional independence scale (MIF) [ 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) ]
    Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions

  3. Catherine Bergego scale (ECB) [ 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) ]
    Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions

  4. Jamar [ 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) ]
    Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213640


Locations
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France
Hôpital henri Gabriel (Hospices Civils de Lyon)
Saint-Genis Laval, France, 69230
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sophie JACQUIN-COURTOIS, MD-PhD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02213640     History of Changes
Other Study ID Numbers: 2013-803
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Keywords provided by Hospices Civils de Lyon:
Neurologic neglect syndrome
post stroke
transcranial direct current stimulation (tDCS)
prismatic adaptation
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes