Neurologic Neglect SyndromePRIStiM1NCT02213640
Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
A study testing transcranial direct current stimulation (tDCS) in people with Neurologic Neglect Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurologic Neglect Syndrome
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 26 Dec 2014to 25 May 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handed
- All subjects must be between the ages of 18-80
- Patient with unilateral negligence consecutive to a right hemispheric stroke
- Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week) or external monitoring
- Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a radiological report
- Diagnosis of negligence evidenced by Behavioural Inattention Test (BIT) : score ≤ 129
- Stroke >1 month prior to study enrollment
Who cannot join
- Degenerative neurological complaint
- Uncontrolled epilepsy
- Temporo-spatial disorientation
- Language disorders or psychiatric disorders preventing understanding instructions
- History of prior stroke, multiple stroke
- Medical condition not stabilized
Show all 10Show fewer
- Pregnancy
- Implanted material (pacemaker, defibrillator, cochlear implant, surgical clips, metal object)
- Intra-cranial material
- Unweaned alcoholism
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital henri Gabriel (Hospices Civils de Lyon)
Saint-Genis-Laval, 69230
About this study
Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term.
Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term.
Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.
- Conditions
- Neurologic Neglect Syndrome
- Being tested
- transcranial direct current stimulation (tDCS), Control: placebo stimulation
- Keywords
- Neurologic neglect syndrome, post stroke, transcranial direct current stimulation (tDCS), prismatic adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
Control: placebo stimulationDevice
electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).
| Study group | Role | What they receive |
|---|---|---|
| Arm A Anodal tDCS and prismatic adaptation | Experimental | anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week). Receives: Device: transcranial direct current stimulation (tDCS) |
| Arm B: control | Placebo comparator | Prismatic adaptation with placebo stimulation Receives: Device: Control: placebo stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural Inattention Test (BIT)
assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion.
Measured: Change in BIT score between the baseline sessions average and score measured at week 11
Secondary outcomes (4)
Negligence Battery Test (BTN)
Change in BTN scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Measured: before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Functional independence scale (MIF)
Change in MIF scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Measured: before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Catherine Bergego scale (ECB)
Change in ECB scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Measured: baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Jamar
Change in Jamar scores between baseline measures before the therapeutic intervention week and scores obtained during each follow-up sessions
Measured: baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study start26 Dec 2014
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurologic Neglect SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie JACQUIN-COURTOIS, MD-PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213640
- Sponsor's protocol ID
- 2013-803
- Acronym
- PRIStiM1
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2014
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
PubMed 34196963Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation
- ClinicalTrials.gov ID
- NCT02213640
- Acronym / sponsor ID
- PRIStiM1 / 2013-803
- Conditions
- Neurologic Neglect Syndrome
- Keywords
- Neurologic neglect syndrome, post stroke, transcranial direct current stimulation (tDCS), prismatic adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Dec 2014 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 11 Aug 2014 (estimated)
- 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.
Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term.
Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term.
Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A Anodal tDCS and prismatic adaptation | Experimental | Device: transcranial direct current stimulation (tDCS)anodal tDCS over the primary motor cortex : stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week). |
| Arm B: control | Placebo comparator | Device: Control: placebo stimulationPrismatic adaptation with placebo stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Right-handed
- All subjects must be between the ages of 18-80
- Patient with unilateral negligence consecutive to a right hemispheric stroke
- Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week) or external monitoring
- Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a radiological report
Key exclusion criteria (10 listed)
- Degenerative neurological complaint
- Uncontrolled epilepsy
- Temporo-spatial disorientation
- Language disorders or psychiatric disorders preventing understanding instructions
- History of prior stroke, multiple stroke
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS)Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week). | Device | Arm A Anodal tDCS and prismatic adaptation |
| Control: placebo stimulationelectrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week). | Device | Arm B: control |
Primary outcome
Behavioural Inattention Test (BIT)
Time frame: Change in BIT score between the baseline sessions average and score measured at week 11
assessed at two baseline sessions before intervention (inclusion and week 3), and after the therapeutic intervention week (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20) following the inclusion.
4 secondary outcomes
Negligence Battery Test (BTN)
Time frame: before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Functional independence scale (MIF)
Time frame: before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Catherine Bergego scale (ECB)
Time frame: baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Jamar
Time frame: baseline session before intervention (week 1 and week 3), and then again following the intervention (week 5), 2 weeks (week 7), 6 weeks (week 11) and 15 weeks (week 20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 34196963Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Related trials for Neurologic Neglect Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN)
Stroke, Unilateral Neglect Syndrome
Recruiting
Using Virtual Reality to Improve Medical Training
Type 2 Diabetes (T2DM), Geriatric Syndromes
RecruitingObservational study
Peripersonal Space Representation in Upper Limb Segmental Exclusion
Segmental Exclusion Syndrome, Complex Regional Pain Syndrome (CRPS)
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
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.
Sophie JACQUIN-COURTOIS, MD-PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Neurologic Neglect Syndrome, run by Hospices Civils de Lyon at 1 site in France.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioural Inattention Test (BIT) (time frame: Change in BIT score between the baseline sessions average and score measured at week 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02213640, which also lists 2 linked publications.
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 14 Aug 2018.