Unilateral Spatial NeglectHEMISTIMNCT05281302
Combination of Neck Muscle Vibration and tDCS With Conventional Rehabilitation in Neglect Patients
A study testing Neck muscle vibration and Neck muscle vibration + anodal-tDCS in people with Unilateral Spatial Neglect, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Spatial Neglect
- What is being tested?
- Neck muscle vibration and Neck muscle vibration + anodal-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to May 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
- Being tested
- Neck muscle vibration, Neck muscle vibration + sham-tDCS, Neck muscle vibration + anodal-tDCS
- Keywords
- Neck muscle vibration, tDCS, conventional rehabilitation, neglect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck muscle vibrationDevice
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-tDCSDevice
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-tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Neck muscle vibration + anodal-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 weeks after the last session of intervention
Secondary outcomes (25)
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.
Measured: at the end of the first week of inclusion
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.
Measured: Immediately following first session of occupational therapy.
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.
Measured: after the first week of protocol
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.
Measured: after the third week of protocol
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.
Measured: 3 weeks after the last session of intervention
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).
Measured: at the end of the first week of inclusion
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).
Measured: Immediately following first session of occupational therapy.
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).
Measured: after the first week of protocol
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).
Measured: After the third week of protocol
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).
Measured: 3 weeks after the last session of intervention
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.
Measured: Immediately following first session of occupational therapy.
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.
Measured: After the first experimental session
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.
Measured: After the first week of protocol
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.
Measured: After the third week of protocol
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.
Measured: 3 weeks after the last session of intervention
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.
Measured: At the end of the first week of inclusion
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.
Measured: Immediately following first session of occupational therapy.
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.
Measured: After the first week of protocol
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.
Measured: After the third week of protocol
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.
Measured: 3 weeks after the last session of intervention
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).
Measured: At the end of the first week of inclusion
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).
Measured: Immediately following first session of occupational therapy.
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).
Measured: After the first week of protocol
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).
Measured: After the third week of protocol
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).
Measured: 3 weeks after the last session of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study startOct 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMay 2028 (estimated)
Why it stopped: Technological problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Spatial NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Lorraine, DevAH (EA3450), Nancy, France, Union de Gestion des Etablissements des Caisses d'Assurance Maladie - PACA, Institut Régional de Médecine Physique et de Réadaptation de Nancy - Etablissement de Lay Saint Christophe
- Responsible party
- Sponsor
- Investigators
- Hadrien Ceyte, PhD, HDR, Study director, Université de Lorraine, DevAH (EA3450), Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281302
- Sponsor's protocol ID
- IRR-LSC-2021-1
- Acronym
- HEMISTIM
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05281302
- Acronym / sponsor ID
- HEMISTIM / IRR-LSC-2021-1
- Conditions
- Unilateral Spatial Neglect
- Keywords
- Neck muscle vibration, tDCS, conventional rehabilitation, neglect
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technological problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Collaborators
- Université de Lorraine, DevAH (EA3450), Nancy, France, Union de Gestion des Etablissements des Caisses d'Assurance Maladie - PACA, Institut Régional de Médecine Physique et de Réadaptation de Nancy - Etablissement de Lay Saint Christophe
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control patients | No intervention | –Patient receiving no additional treatment to conventional occupational therapy sessions |
| left-NMV | Experimental | Device: Neck muscle vibrationPatient will be equipped with vibratory stimulators during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated. |
| left-NMV + sham-tDCS | Sham comparator | Device: Neck muscle vibration + sham-tDCSPatient 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. |
| left-NMV + anodal-tDCS | Experimental | Device: Neck muscle vibration + anodal-tDCSPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck muscle vibrationPatient 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 | left-NMV |
| Neck muscle vibration + sham-tDCSPatient 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 | left-NMV + sham-tDCS |
| Neck muscle vibration + anodal-tDCSPatient 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. | Device | left-NMV + anodal-tDCS |
Primary outcome
Catherine Bergego Scale
Time frame: at the end of the first week of inclusion
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
Catherine Bergego Scale
Time frame: Immediately following first session of occupational therapy.
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
Catherine Bergego Scale
Time frame: after the first week of protocol
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
Catherine Bergego Scale
Time frame: after the third week of protocol
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
Catherine Bergego Scale
Time frame: 3 weeks after the last session of intervention
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
25 secondary outcomes
Fluff test
Time frame: at the end of the first week of inclusion
Fluff test
Time frame: Immediately following first session of occupational therapy.
Fluff test
Time frame: after the first week of protocol
Fluff test
Time frame: after the third week of protocol
Fluff test
Time frame: 3 weeks after the last session of intervention
Gainotti's drawing copying test
Time frame: at the end of the first week of inclusion
Gainotti's drawing copying test
Time frame: Immediately following first session of occupational therapy.
Gainotti's drawing copying test
Time frame: after the first week of protocol
Gainotti's drawing copying test
Time frame: After the third week of protocol
Gainotti's drawing copying test
Time frame: 3 weeks after the last session of intervention
The Map of France test
Time frame: Immediately following first session of occupational therapy.
The Map of France test
Time frame: After the first experimental session
The Map of France test
Time frame: After the first week of protocol
The Map of France test
Time frame: After the third week of protocol
The Map of France test
Time frame: 3 weeks after the last session of intervention
The Subjective Straight-Ahead test
Time frame: At the end of the first week of inclusion
The Subjective Straight-Ahead test
Time frame: Immediately following first session of occupational therapy.
The Subjective Straight-Ahead test
Time frame: After the first week of protocol
The Subjective Straight-Ahead test
Time frame: After the third week of protocol
The Subjective Straight-Ahead test
Time frame: 3 weeks after the last session of intervention
The Wheelchair navigation test
Time frame: At the end of the first week of inclusion
The Wheelchair navigation test
Time frame: Immediately following first session of occupational therapy.
The Wheelchair navigation test
Time frame: After the first week of protocol
The Wheelchair navigation test
Time frame: After the third week of protocol
The Wheelchair navigation test
Time frame: 3 weeks after the last session of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadrien Ceyte, PhD, HDR study director
Université de Lorraine, DevAH (EA3450), Nancy, France
Questions about this trial
What is this clinical trial studying?
A study testing Neck muscle vibration and Neck muscle vibration + anodal-tDCS in people with Unilateral Spatial Neglect, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catherine Bergego Scale (time frame: at the end of the first week of inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.