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OpenTrials
Completed

NCT Number: NCT02213640

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

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.

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Key information

Conditions

Neurologic Neglect Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital henri Gabriel (Hospices Civils de Lyon)

Saint-Genis-Laval, 69230, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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

Control: placebo stimulation

Device

electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PRIStiM1

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2014
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.