Clinical trial NCT05281302: Combination of Neck Muscle Vibration and tDCS With Conventional Rehabilitation in Neglect Patients
Official title: Innovative Therapy Combining Neck Muscle Vibration and Transcranial Direct Current Stimulation in Association With Conventional Rehabilitation in Left Unilateral Spatial Neglect Patients: HEMISTIM Protocol
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Unilateral Spatial Neglect
Keywords: Neck muscle vibration
tDCS
conventional rehabilitation
neglect
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
Collaborators: name: Université de Lorraine, DevAH (EA3450), Nancy, France
name: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - PACA
name: Institut Régional de Médecine Physique et de Réadaptation de Nancy - Etablissement de Lay Saint Christophe
First posted: 2022-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Unilateral spatial neglect (USN) rehabilitation remains a challenge and requires the development of new methods that can be easily integrated into conventional practice. The aim of the HEMISTIM protocol is to assess immediate and long-term functional outcomes and neuropsychological aspects of recovery, induced by an innovative association of left-side neck-muscle vibration (NMV) and anodal transcranial Direct Current Stimulation (tDCS) on the ipsilesional posterior parietal cortex during occupational therapy sessions in patients with left USN.

METHODS: Participants will be randomly assigned to 4 groups: control, Left-NMV, Left-NMV + sham-tDCS or Left-NMV + anodal-tDCS. NMV will be applied during the first 15 minutes of occupational therapy and tDCS will be applied for 20 minutes, starting 5 minutes before, three days a week for three weeks. USN will be assessed at baseline, just at the end of the first experimental session, after the first and third weeks of the protocol and three weeks after its ending.

DISCUSSION: Left NMV, by activating multisensory integration neuronal networks, might enhance beneficial effects obtained by conventional occupational therapy sessions since interesting post-effects were shown when it was combined with voluntary upper limb movements. The investigators expect to reinforce lasting intermodal recalibration through LTP-like plasticity induced by anodal tDCS. The HEMISTIM protocol represents a therapeutic innovation associated to conventional practice that could provide a partial solution to the rehabilitation challenges of the USN syndrome and some insights to its underlying mechanisms.


Eligibility criteria: Inclusion Criteria:

* admitted in a post-stroke rehabilitation unit in the sub-acute phase (15 days to 6 months from the onset of stroke symptoms)
* at least 18 years old
* a first unilateral right hemispheric stroke
* diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
* Behavioral Inattention Test (c-BIT), inferior or equal to 129

Exclusion Criteria:

* unable to give informed consent
* pregnant women
* patients with skin lesions on the areas for electrode placement
* having history of metal-in-cranial injury
* epilepsy
* vestibulo-cochlear illness
* cardiac pacemaker

Primary outcomes:
measure: Catherine Bergego Scale
timeFrame: at the end of the first week of inclusion
measure: Catherine Bergego Scale
timeFrame: Immediately following first session of occupational therapy.
measure: Catherine Bergego Scale
timeFrame: after the first week of protocol
measure: Catherine Bergego Scale
timeFrame: after the third week of protocol
measure: Catherine Bergego Scale
timeFrame: 3 weeks after the last session of intervention
Secondary outcomes:
measure: Fluff test
timeFrame: at the end of the first week of inclusion
measure: Fluff test
timeFrame: Immediately following first session of occupational therapy.
measure: Fluff test
timeFrame: after the first week of protocol
measure: Fluff test
timeFrame: after the third week of protocol
measure: Fluff test
timeFrame: 3 weeks after the last session of intervention
measure: Gainotti's drawing copying test
timeFrame: at the end of the first week of inclusion
measure: Gainotti's drawing copying test
timeFrame: Immediately following first session of occupational therapy.
measure: Gainotti's drawing copying test
timeFrame: after the first week of protocol
measure: Gainotti's drawing copying test
timeFrame: After the third week of protocol
measure: Gainotti's drawing copying test
timeFrame: 3 weeks after the last session of intervention
measure: The Map of France test
timeFrame: Immediately following first session of occupational therapy.
measure: The Map of France test
timeFrame: After the first experimental session
measure: The Map of France test
timeFrame: After the first week of protocol
measure: The Map of France test
timeFrame: After the third week of protocol
measure: The Map of France test
timeFrame: 3 weeks after the last session of intervention
measure: The Subjective Straight-Ahead test
timeFrame: At the end of the first week of inclusion
measure: The Subjective Straight-Ahead test
timeFrame: Immediately following first session of occupational therapy.
measure: The Subjective Straight-Ahead test
timeFrame: After the first week of protocol
measure: The Subjective Straight-Ahead test
timeFrame: After the third week of protocol
measure: The Subjective Straight-Ahead test
timeFrame: 3 weeks after the last session of intervention
measure: The Wheelchair navigation test
timeFrame: At the end of the first week of inclusion
measure: The Wheelchair navigation test
timeFrame: Immediately following first session of occupational therapy.
measure: The Wheelchair navigation test
timeFrame: After the first week of protocol
measure: The Wheelchair navigation test
timeFrame: After the third week of protocol
measure: The Wheelchair navigation test
timeFrame: 3 weeks after the last session of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Université de Lorraine, DevAH (EA3450), Nancy, France
name: Hadrien Ceyte, PhD, HDR
role: STUDY_DIRECTOR
References: