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

NCT05281302 | Withdrawn

• 1 other identifier: IRR-LSC-2021-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Neck muscle vibration; tDCS; conventional rehabilitation; neglect

Outcome Measures

Primary Outcomes (5)

• Catherine Bergego Scale

  Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect

  at the end of the first week of inclusion

• Catherine Bergego Scale

  Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect

  Immediately following first session of occupational therapy.

• Catherine Bergego Scale

  Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect

  after the first week of protocol

• Catherine Bergego Scale

  Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect

  after the third week of protocol

• Catherine Bergego Scale

  Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect

  3 weeks after the last session of intervention

Secondary Outcomes (25)

• Fluff test

  at the end of the first week of inclusion

• Fluff test

  Immediately following first session of occupational therapy.

• Fluff test

  after the first week of protocol

• Fluff test

  after the third week of protocol

• Fluff test

  3 weeks after the last session of intervention

Study Arms (4)

Control patients

NO INTERVENTION

Patient receiving no additional treatment to conventional occupational therapy sessions

left-NMV

EXPERIMENTAL

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

Device: Neck muscle vibration

left-NMV + sham-tDCS

SHAM COMPARATOR

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.

Device: Neck muscle vibration + sham-tDCS

left-NMV + anodal-tDCS

EXPERIMENTAL

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.

Device: Neck muscle vibration + anodal-tDCS

Interventions

Neck muscle vibration 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

Neck muscle vibration + sham-tDCS 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 + sham-tDCS

Neck muscle vibration + anodal-tDCS 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.

left-NMV + anodal-tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est: lead
• Université de Lorraine, DevAH (EA3450), Nancy, France: collaborator
• Union de Gestion des Etablissements des Caisses d'Assurance Maladie - PACA: collaborator
• Institut Régional de Médecine Physique et de Réadaptation de Nancy - Etablissement de Lay Saint Christophe: collaborator

Study Officials

• Hadrien Ceyte, PhD, HDR

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 16, 2022
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share