Combination of Neck Muscle Vibration and tDCS With Conventional Rehabilitation in Neglect Patients (HEMISTIM)

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Status: Withdrawn

Conditions: Unilateral Spatial Neglect

Treatments: Device: Neck muscle vibration; Device: Neck muscle vibration + sham-tDCS; Device: Neck muscle vibration + anodal-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05281302

IRR-LSC-2021-1

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

Control patients

No Intervention group

Description:

Patient receiving no additional treatment to conventional occupational therapy sessions

left-NMV

Experimental group

Description:

Patient will be equipped with vibratory stimulators during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.

Treatment:

Device: Neck muscle vibration

left-NMV + sham-tDCS

Sham Comparator group

Description:

Patient will be equipped with vibratory stimulators and with electrodes form sham-tDCS during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.

Treatment:

Device: Neck muscle vibration + sham-tDCS

left-NMV + anodal-tDCS

Experimental group

Description:

Patient will be equipped with vibratory stimulators and with electrodes for tDCS during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.

Treatment:

Device: Neck muscle vibration + anodal-tDCS