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

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.

Study Overview

• Status: Completed
• Conditions: Neurologic Neglect Syndrome
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS); Device: Control: placebo stimulation

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Genis Laval, France, 69230
    • Hôpital henri Gabriel (Hospices Civils de Lyon)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in BIT score between the baseline sessions average and score measured at week 11

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sophie JACQUIN-COURTOIS, MD-PhD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2014
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): May 25, 2018

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 8, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation (tDCS); prismatic adaptation; Neurologic neglect syndrome; post stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 2013-803