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

Unilateral Spatial Neglect Clinical Trial

— HEMISTIM  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05281302
• Other study ID #: IRR-LSC-2021-1
• Status: Withdrawn
• Phase: N/A
• Start date: October 2024
• Est. completion date: May 2028

Study information

• Verified date: February 2024
• Source: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2028
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perceptual Disorders
• Unilateral Spatial Neglect

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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
Primary	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
Primary	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	Fluff test	Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.	at the end of the first week of inclusion
Secondary	Fluff test	Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.	Immediately following first session of occupational therapy.
Secondary	Fluff test	Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.	after the first week of protocol
Secondary	Fluff test	Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.	after the third week of protocol
Secondary	Fluff test	Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.	3 weeks after the last session of intervention
Secondary	Gainotti's drawing copying test	Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).	at the end of the first week of inclusion
Secondary	Gainotti's drawing copying test	Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).	Immediately following first session of occupational therapy.
Secondary	Gainotti's drawing copying test	Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).	after the first week of protocol
Secondary	Gainotti's drawing copying test	Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).	After the third week of protocol
Secondary	Gainotti's drawing copying test	Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).	3 weeks after the last session of intervention
Secondary	The Map of France test	The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.	Immediately following first session of occupational therapy.
Secondary	The Map of France test	The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.	After the first experimental session
Secondary	The Map of France test	The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.	After the first week of protocol
Secondary	The Map of France test	The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.	After the third week of protocol
Secondary	The Map of France test	The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.	3 weeks after the last session of intervention
Secondary	The Subjective Straight-Ahead test	Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.	At the end of the first week of inclusion
Secondary	The Subjective Straight-Ahead test	Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.	Immediately following first session of occupational therapy.
Secondary	The Subjective Straight-Ahead test	Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.	After the first week of protocol
Secondary	The Subjective Straight-Ahead test	Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.	After the third week of protocol
Secondary	The Subjective Straight-Ahead test	Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.	3 weeks after the last session of intervention
Secondary	The Wheelchair navigation test	Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).	At the end of the first week of inclusion
Secondary	The Wheelchair navigation test	Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).	Immediately following first session of occupational therapy.
Secondary	The Wheelchair navigation test	Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).	After the first week of protocol
Secondary	The Wheelchair navigation test	Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).	After the third week of protocol
Secondary	The Wheelchair navigation test	Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).	3 weeks after the last session of intervention