NCT05281302

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

Innovative Therapy Combining Neck Muscle Vibration and Transcranial Direct Current Stimulation in Association With Conventional Rehabilitation in Left Unilateral Spatial Neglect Patients: HEMISTIM Protocol

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unilateral Spatial Neglect

Interventions

Type	Name	Description
DEVICE	Neck muscle vibration	Patient will receive neck muscle vibration during the first 15 minutes of occupational therapy. Vibratory stimulators will be fixed bilaterally on the skin over the belly of the trapezius muscles and fastened with straps. Only the left vibrator will be activated.
DEVICE	Neck muscle vibration + sham-tDCS	Patient will receive neck muscle vibration during the first 15 minutes of occupational therapy.. Vibratory stimulators will be fixed bilaterally on the skin over the belly of the trapezius muscles and fastened with straps. Only the left vibrator will be activated. Moreover, tDCS will be applied using an electrical stimulator (DC-STIMULATOR®, NeuroCare, Illmenau, Germany) through large saline-soaked sponge surface electrodes placed as follows: anode over the right (ipsilesional) posterior parietal cortex (P4 according to the International 10-20 EEG electrode placement system) and cathode over the left supraorbital region. The tDCS will be automatically turned off after 20 seconds. This allows the reproduction of the initial mild itching sensation at the beginning of active tDCS, thus ensuring that the patient stays blind to the activation status of the device.
DEVICE	Neck muscle vibration + anodal-tDCS	Patient will receive neck muscle vibration during the first 15 minutes of occupational therapy. Vibratory stimulators will be fixed bilaterally on the skin over the belly of the trapezius muscles and fastened with straps. Only the left vibrator will be activated. Moreover, tDCS will be applied using an electrical stimulator (DC-STIMULATOR®, NeuroCare, Illmenau, Germany) through large saline-soaked sponge surface electrodes placed as follows: anode over the right (ipsilesional) posterior parietal cortex (P4 according to the International 10-20 EEG electrode placement system) and cathode over the left supraorbital region. A continuous 2 mA current will be delivered for 20 minutes simultaneously to NMV stimulation. The stimulation will begin 5 minutes before the beginning of occupational therapy.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-10-01
• Completion: 2028-05-01
• First posted: 2022-03-16
• Last updated: 2024-02-07