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

NCT ID: NCT05281302

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2028-05-31

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.

Conditions

Unilateral Spatial Neglect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control patients

Patient receiving no additional treatment to conventional occupational therapy sessions

Group Type: NO_INTERVENTION

No interventions assigned to this group

left-NMV

Patient will be equipped with vibratory stimulators during conventional occupational therapy sessions.

Only the left-side NMV vibrator will be activated.

Group Type: EXPERIMENTAL

Neck muscle vibration

Intervention Type: DEVICE

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.

left-NMV + sham-tDCS

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.

Group Type: SHAM_COMPARATOR

Neck muscle vibration + sham-tDCS

Intervention Type: DEVICE

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.

left-NMV + anodal-tDCS

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.

Group Type: EXPERIMENTAL

Neck muscle vibration + anodal-tDCS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Lorraine, DevAH (EA3450), Nancy, France

UNKNOWN

Sponsor Role: collaborator

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - PACA

UNKNOWN

Sponsor Role: collaborator

Institut Régional de Médecine Physique et de Réadaptation de Nancy - Etablissement de Lay Saint Christophe

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hadrien Ceyte, PhD, HDR

Role: STUDY_DIRECTOR

Université de Lorraine, DevAH (EA3450), Nancy, France

Other Identifiers

IRR-LSC-2021-1

Identifier Type: -

Identifier Source: org_study_id