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

Civil Hospices of Lyon

Status: Completed

Conditions: Neurologic Neglect Syndrome

Treatments: Device: transcranial direct current stimulation (tDCS); Device: Control: placebo stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02213640

2013-803

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Arm A Anodal tDCS and prismatic adaptation

Experimental group

Description:

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

Treatment:

Device: transcranial direct current stimulation (tDCS)

Arm B: control

Placebo Comparator group

Description:

Prismatic adaptation with placebo stimulation

Treatment:

Device: Control: placebo stimulation