Clinical trial NCT02213640: Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
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
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Neglect Syndrome
Keywords: Neurologic neglect syndrome
post stroke
transcranial direct current stimulation (tDCS)
prismatic adaptation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Behavioural Inattention Test (BIT)
timeFrame: Change in BIT score between the baseline sessions average and score measured at week 11
Secondary outcomes:
measure: Negligence Battery Test (BTN)
timeFrame: 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)
measure: Functional independence scale (MIF)
timeFrame: 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)
measure: Catherine Bergego scale (ECB)
timeFrame: 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)
measure: Jamar
timeFrame: 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)
Other outcomes:
Locations:
city: Saint-Genis Laval
country: France
facility: Hôpital henri Gabriel (Hospices Civils de Lyon)
Study officials:
affiliation: Hospices Civils de Lyon
name: Sophie JACQUIN-COURTOIS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.