Brain InjuryREDACTNCT06888219
Somatic and Ear Acupuncture for Dysphagia Rehabilitation and Decannulation After Severe Acquired Brain Injuries
A study testing Acupuncture and Auricolotherapy and Conventional logopedic rehabilitation in people with Brain Injury and Cognitive Impairment, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The goal of this interventional, randomized, controlled, double-blind pilot study is to assess the superiority of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, for the treatment of dysphagia in patients with severe Acquired Brain Injury (sABI) of vascular etiology, who are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Cognitive Impairment, Deglutition Disorder
- What is being tested?
- Acupuncture and Auricolotherapy and Conventional logopedic rehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 25 Nov 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of severe Acquired Brain Injury with vascular etiology (ischemic or hemorrhagic), confirmed by Computerized Tomography or Magnetic Resonance Imaging.
- Time between acute event and enrollment: 1 to 3 months. Age >18 years. Presence of a tracheal cannula upon admission to the Intensive Rehabilitation Unit.
- Level of Cognitive Functioning (LCF) < or = 4. Informed consent signed by the patient's legal representative.
Who cannot join
- Instability of general clinical conditions, including mechanical ventilation, sedation, sepsis or sub-emergent epileptic seizures.
- Patients in Unresponsive Wakefulness Syndrome (UWS), according to the Coma Recovery Scale-Revised (CRS-R).
- Known agoraphobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: REhabilitation of Dysphagia with ACupuncture and AuriculoTherapy in Non-communicative Patients with Severe Acquired Brain Injury (REDACT-Study): a Pilot Controlled Randomized Double Blinded Trial Study Protocol
The goal of this interventional, randomized, controlled, double-blind pilot study is to assess the superiority of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, for the treatment of dysphagia in patients with severe Acquired Brain Injury (sABI) of vascular etiology, who are tracheostomized and have severe cognitive impairment, classified as Level of Cognitive Functioning (LCF) <4 according to the LCF Scale.
The main questions this study aims to answer are:
Read more
- Does a treatment of 10 sessions of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, help reduce dysphagia, as measured by clinical and instrumental scales, and shorten the time to decannulation after 4 weeks of treatment?
- Is the obtained result maintained 3 months after the end of the rehabilitation treatment?
Researchers will compare patients receiving conventional speech therapy rehabilitation with those also undergoing 10 sessions of Acupuncture and Auriculotherapy to determine whether this ancient Chinese technique can improve dysphagia and reduce time to decannulation in patients with vascular sABI and severe cognitive impairment.
Participants will be assigned to either the Intervention Group (Acupuncture and Auriculotherapy in addition to conventional rehabilitation) or the Control Group (conventional rehabilitation only). In both groups, conventional speech therapy rehabilitation will consist of 1 hour of treatment per day. The Intervention Group will undergo additional rehabilitation treatment using specific acupuncture and auriculotherapy points.
Read the detailed description
On admission to the Intensive Rehabilitation Unit (IRU), patients with severe Acquired Brain Injury (sABI) often present with severe dysphagia (incidence up to 93%) and require a tracheal cannula (50-70%). During this intensive rehabilitation phase, the restoration of oral feeding and decannulation are two crucial and closely linked objectives. Studies have shown that the inability to manage saliva and dysphagia represents the main obstacle to decannulation, even in the long term.
Due to the extreme heterogeneity of patients with sABI and the lack of guidelines and consensus on the modalities and timing of dysphagia rehabilitation, swallowing rehabilitation still lacks standardization. Furthermore, most dysphagia rehabilitation techniques (both compensatory and restorative) require a certain degree of active patient collaboration, making them difficult to apply in sub-acute sABI patients.
In this context, acupuncture, which is already recommended by various international guidelines for conditions such as spasticity and pain, could be a valid therapeutic option. In fact, this technique has shown potential in reducing sialorrhea and muscular contractures in the oro-facial area, even in non-cooperative patients, such as those with a Disorder of Consciousness (DoC) or cognitive impairment.
This study aims to verify the effectiveness of Acupuncture and Auriculotherapy in the rehabilitation of dysphagia and tracheal cannula weaning in non-cooperative patients with sABI outcomes. The goal is to support the use of a safe, low-cost, bedside technique with no side effects, potentially applicable in all settings and during all rehabilitation phases.
The study will enroll 24 patients admitted to the IRU of the IRCCS-Fondazione Don Gnocchi of Florence for sABI of vascular etiology.
The baseline assessment (T0) at the time of study inclusion will involve the administration of clinical-instrumental scales to measure dysphagia severity:
- Mann Assessment of Swallowing Ability (MASA), assessed by the speech therapist
- Pooling Score, assessed by the phoniatrist using Fiberoptic Endoscopic Evaluation of Swallowing (FEES) A computerized randomization will assign patients to either the Intervention Group or the Control Group.
In both groups, conventional speech therapy rehabilitation will involve 1 hour per day of treatment, including restorative or passive compensatory interventions (e.g., modifications in food consistency and posture, passive exercises to improve swallowing structures) and the standard protocol for tracheal cannula weaning.
The Intervention Group will also undergo 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes.
A follow-up clinical-instrumental assessment is scheduled:
At the end of 4 weeks of treatment (T1) At 3 months after T0 (T2)
- Conditions
- Brain Injury, Cognitive Impairment, Deglutition Disorder
- Being tested
- Acupuncture and Auricolotherapy, Conventional logopedic rehabilitation
- Keywords
- tracheostomy tube, acupuncture
- Medical subject headings
- Brain Injuries, Cognitive Dysfunction, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and AuricolotherapyOther
Based on the patient's condition and the physiology of traditional Chinese medicine, sterile disposable acupuncture needles will be placed on selected points:
Auricular:
- Esophagus point
- Shen Men point
- Palate area/ Throat point
- II and III Trigeminal branches
Somatic:
- 17 Triple heater (if bruxisme)
- 22 Conception Vessel
- 23 Conception Vessel
- 3 Small Intestine
- Yin Tang (if apathy)
- 3 Large Intestine (if xerostomy)
- 36 and 44 Stomach
Conventional logopedic rehabilitationOther
Patients assigned to the control arm will undergo a total of 3 hours of speech and physiotherapy rehabilitation per day from Monday to Friday, and 1 hour on Saturday.
Regarding speech therapy treatment, both restorative and compensatory interventions will be applied, based on the patient's clinical condition.
Compensatory approaches include postural techniques (such as adopting a flexed head posture) and swallowing techniques (e.g., supraglottic swallowing, forced swallowing, the Mendelsohn maneuver), as well as modifying the consistency of liquids and food.
Restorative methods involve swallowing exercises aimed at enhancing muscular strength, resistance training, and motor training of the oral structures involved in swallowing.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and Auriculotherapy | Experimental | Patients assigned to the intervention arm will receive conventional speech therapy rehabilitation (as in the control group) along with 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes. The treatment will follow a protocol developed in collaboration with experienced acupuncture physicians and will involve the placement of approximately 10 somatic and auricular needles. Receives: Other: Acupuncture and Auricolotherapy; Other: Conventional logopedic rehabilitation |
| Conventional speech therapy rehabilitation | Active comparator | Patients assigned to the control arm will undergo conventional speech therapy rehabilitation, which involves one hour per day of treatment, including restorative or passive compensatory interventions (e.g., modifications in food consistency and posture, passive exercises to improve swallowing structures) and the standard protocol for tracheal cannula weaning. Receives: Other: Conventional logopedic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant difference measured by Mann Assessment of Swallowing Ability (MASA) Scale
The Mann Assessment of Swallowing Ability (MASA) Scale consists of 26 items. The sum of the individual scores provides a total score that categorizes dysphagia and aspiration into four levels of severity.
Dysphagia severity: The highest possible score is 200. 200-178: No abnormality detected 177-168: Mild dysphagia 167-139: Moderate dysphagia Below 138: Severe dysphagia (worst possible grade)
Aspiration severity: The highest possible score is 200. 200-170: No abnormality detected 169-149: Mild aspiration 148-140: Moderate aspiration Below 140: Severe aspiration (worst possible grade)
Measured: From enrollment to the end of treatment at 4 weeks and at 3 months
Significant difference measured by Pooling Score, based on endoscopic landmarks and bedside parameters with relative values
The Pooling Score is a clinical endoscopic evaluation used to assess the severity of swallowing disorders, considering excess residue in the pharynx and larynx.
The score ranges from a minimum of 4 to a maximum of 11 and is calculated by summing the scores assigned to:
Bolus location Amount of residue Ability to control residue/bolus pooling, assessed based on coughing, throat clearing (raclage), and the number of dry voluntary or reflex swallowing attempts (<2, 2-5, >5).
Measured: From enrollment to the end of treatment at 4 weeks and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start25 Nov 2024
- Primary completion25 Nov 2024
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahia Hakiki, Principal investigator, IRCCS-Fondazione Don Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888219
- Sponsor's protocol ID
- REDACT
- Acronym
- REDACT
- Status last verified
- Oct 2024
- First submitted
- 13 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.
PubMed 27006423Garuti G, Reverberi C, Briganti A, Massobrio M, Lombardi F, Lusuardi M. Swallowing disorders in tracheostomised patients: a multidisciplinary/multiprofessional approach in decannulation protocols. Multidiscip Respir Med. 2014 Jun 20;9(1):36. doi: 10.1186/2049-6958-9-36. eCollection 2014.
PubMed 25006457Hakiki B, Draghi F, Pancani S, Portaccio E, Grippo A, Binazzi B, Tofani A, Scarpino M, Macchi C, Cecchi F. Decannulation After a Severe Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Nov;101(11):1906-1913. doi: 10.1016/j.apmr.2020.05.004. Epub 2020 May 16.
PubMed 32428445Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.
PubMed 18646575Calamini M, De Nisco A, Draghi F, Cecchi F, Graziani P, Grippo A, Macchi C, Maccanti D, Romoli A, Pancani S, Guido C, Hakiki B. REhabilitation of Dysphagia with ACupuncture and auricular Therapy after severe acquired brain injury (REDACT study): a double-blind randomized controlled trial protocol. Front Neurol. 2026 Feb 24;17:1724043. doi: 10.3389/fneur.2026.1724043. eCollection 2026.
PubMed 41815729
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REhabilitation of Dysphagia with ACupuncture and AuriculoTherapy in Non-communicative Patients with Severe Acquired Brain Injury (REDACT-Study): a Pilot Controlled Randomized Double Blinded Trial Study Protocol
- ClinicalTrials.gov ID
- NCT06888219
- Acronym / sponsor ID
- REDACT / REDACT
- Conditions
- Brain Injury, Cognitive Impairment, Deglutition Disorder
- Keywords
- tracheostomy tube, acupuncture
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Mar 2025 (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.
The goal of this interventional, randomized, controlled, double-blind pilot study is to assess the superiority of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, for the treatment of dysphagia in patients with severe Acquired Brain Injury (sABI) of vascular etiology, who are tracheostomized and have severe cognitive impairment, classified as Level of Cognitive Functioning (LCF) <4 according to the LCF Scale.
The main questions this study aims to answer are:
- Does a treatment of 10 sessions of Acupuncture and Auriculotherapy, in addition to conventional speech therapy rehabilitation, help reduce dysphagia, as measured by clinical and instrumental scales, and shorten the time to decannulation after 4 weeks of treatment?
- Is the obtained result maintained 3 months after the end of the rehabilitation treatment?
Researchers will compare patients receiving conventional speech therapy rehabilitation with those also undergoing 10 sessions of Acupuncture and Auriculotherapy to determine whether this ancient Chinese technique can improve dysphagia and reduce time to decannulation in patients with vascular sABI and severe cognitive impairment.
Participants will be assigned to either the Intervention Group (Acupuncture and Auriculotherapy in addition to conventional rehabilitation) or the Control Group (conventional rehabilitation only). In both groups, conventional speech therapy rehabilitation will consist of 1 hour of treatment per day. The Intervention Group will undergo additional rehabilitation treatment using specific acupuncture and auriculotherapy points.
Detailed description
On admission to the Intensive Rehabilitation Unit (IRU), patients with severe Acquired Brain Injury (sABI) often present with severe dysphagia (incidence up to 93%) and require a tracheal cannula (50-70%). During this intensive rehabilitation phase, the restoration of oral feeding and decannulation are two crucial and closely linked objectives. Studies have shown that the inability to manage saliva and dysphagia represents the main obstacle to decannulation, even in the long term.
Due to the extreme heterogeneity of patients with sABI and the lack of guidelines and consensus on the modalities and timing of dysphagia rehabilitation, swallowing rehabilitation still lacks standardization. Furthermore, most dysphagia rehabilitation techniques (both compensatory and restorative) require a certain degree of active patient collaboration, making them difficult to apply in sub-acute sABI patients.
In this context, acupuncture, which is already recommended by various international guidelines for conditions such as spasticity and pain, could be a valid therapeutic option. In fact, this technique has shown potential in reducing sialorrhea and muscular contractures in the oro-facial area, even in non-cooperative patients, such as those with a Disorder of Consciousness (DoC) or cognitive impairment.
This study aims to verify the effectiveness of Acupuncture and Auriculotherapy in the rehabilitation of dysphagia and tracheal cannula weaning in non-cooperative patients with sABI outcomes. The goal is to support the use of a safe, low-cost, bedside technique with no side effects, potentially applicable in all settings and during all rehabilitation phases.
The study will enroll 24 patients admitted to the IRU of the IRCCS-Fondazione Don Gnocchi of Florence for sABI of vascular etiology.
The baseline assessment (T0) at the time of study inclusion will involve the administration of clinical-instrumental scales to measure dysphagia severity:
- Mann Assessment of Swallowing Ability (MASA), assessed by the speech therapist
- Pooling Score, assessed by the phoniatrist using Fiberoptic Endoscopic Evaluation of Swallowing (FEES) A computerized randomization will assign patients to either the Intervention Group or the Control Group.
In both groups, conventional speech therapy rehabilitation will involve 1 hour per day of treatment, including restorative or passive compensatory interventions (e.g., modifications in food consistency and posture, passive exercises to improve swallowing structures) and the standard protocol for tracheal cannula weaning.
The Intervention Group will also undergo 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes.
A follow-up clinical-instrumental assessment is scheduled:
At the end of 4 weeks of treatment (T1) At 3 months after T0 (T2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and Auriculotherapy | Experimental | Other: Acupuncture and Auricolotherapy, Other: Conventional logopedic rehabilitationPatients assigned to the intervention arm will receive conventional speech therapy rehabilitation (as in the control group) along with 2 or 3 weekly sessions of Acupuncture and Auriculotherapy, each lasting 20 minutes. The treatment will follow a protocol developed in collaboration with experienced acupuncture physicians and will involve the placement of approximately 10 somatic and auricular needles. |
| Conventional speech therapy rehabilitation | Active comparator | Other: Conventional logopedic rehabilitationPatients assigned to the control arm will undergo conventional speech therapy rehabilitation, which involves one hour per day of treatment, including restorative or passive compensatory interventions (e.g., modifications in food consistency and posture, passive exercises to improve swallowing structures) and the standard protocol for tracheal cannula weaning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of severe Acquired Brain Injury with vascular etiology (ischemic or hemorrhagic), confirmed by Computerized Tomography or Magnetic Resonance Imaging.
- Time between acute event and enrollment: 1 to 3 months. Age >18 years. Presence of a tracheal cannula upon admission to the Intensive Rehabilitation Unit.
- Level of Cognitive Functioning (LCF) < or = 4. Informed consent signed by the patient's legal representative.
Key exclusion criteria (3 listed)
- Instability of general clinical conditions, including mechanical ventilation, sedation, sepsis or sub-emergent epileptic seizures.
- Patients in Unresponsive Wakefulness Syndrome (UWS), according to the Coma Recovery Scale-Revised (CRS-R).
- Known agoraphobia.
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 |
|---|---|---|
| Acupuncture and AuricolotherapyBased on the patient's condition and the physiology of traditional Chinese medicine, sterile disposable acupuncture needles will be placed on selected points: Auricular: * Esophagus point * Shen Men point * Palate area/ Throat point * II and III Trigeminal branches Somatic: * 17 Triple heater (if bruxisme) * 22 Conception Vessel * 23 Conception Vessel * 3 Small Intestine * Yin Tang (if apathy) * 3 Large Intestine (if xerostomy) * 36 and 44 Stomach | Other | Acupuncture and Auriculotherapy |
| Conventional logopedic rehabilitationPatients assigned to the control arm will undergo a total of 3 hours of speech and physiotherapy rehabilitation per day from Monday to Friday, and 1 hour on Saturday. Regarding speech therapy treatment, both restorative and compensatory interventions will be applied, based on the patient's clinical condition. Compensatory approaches include postural techniques (such as adopting a flexed head posture) and swallowing techniques (e.g., supraglottic swallowing, forced swallowing, the Mendelsohn maneuver), as well as modifying the consistency of liquids and food. Restorative methods involve swallowing exercises aimed at enhancing muscular strength, resistance training, and motor training of the oral structures involved in swallowing. | Other | Acupuncture and Auriculotherapy, Conventional speech therapy rehabilitation |
Primary outcome
Significant difference measured by Mann Assessment of Swallowing Ability (MASA) Scale
Time frame: From enrollment to the end of treatment at 4 weeks and at 3 months
The Mann Assessment of Swallowing Ability (MASA) Scale consists of 26 items. The sum of the individual scores provides a total score that categorizes dysphagia and aspiration into four levels of severity. Dysphagia severity: The highest possible score is 200. 200-178: No abnormality detected 177-168: Mild dysphagia 167-139: Moderate dysphagia Below 138: Severe dysphagia (worst possible grade) Aspiration severity: The highest possible score is 200. 200-170: No abnormality detected 169-149: Mild aspiration 148-140: Moderate aspiration Below 140: Severe aspiration (worst possible grade)
Significant difference measured by Pooling Score, based on endoscopic landmarks and bedside parameters with relative values
Time frame: From enrollment to the end of treatment at 4 weeks and at 3 months
The Pooling Score is a clinical endoscopic evaluation used to assess the severity of swallowing disorders, considering excess residue in the pharynx and larynx. The score ranges from a minimum of 4 to a maximum of 11 and is calculated by summing the scores assigned to: Bolus location Amount of residue Ability to control residue/bolus pooling, assessed based on coughing, throat clearing (raclage), and the number of dry voluntary or reflex swallowing attempts (<2, 2-5, >5).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 27006423Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.
- Background: PubMed 25006457Garuti G, Reverberi C, Briganti A, Massobrio M, Lombardi F, Lusuardi M. Swallowing disorders in tracheostomised patients: a multidisciplinary/multiprofessional approach in decannulation protocols. Multidiscip Respir Med. 2014 Jun 20;9(1):36. doi: 10.1186/2049-6958-9-36. eCollection 2014.
- Background: PubMed 32428445Hakiki B, Draghi F, Pancani S, Portaccio E, Grippo A, Binazzi B, Tofani A, Scarpino M, Macchi C, Cecchi F. Decannulation After a Severe Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Nov;101(11):1906-1913. doi: 10.1016/j.apmr.2020.05.004. Epub 2020 May 16.
- Background: PubMed 18646575Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.
- Derived from this study: PubMed 41815729Calamini M, De Nisco A, Draghi F, Cecchi F, Graziani P, Grippo A, Macchi C, Maccanti D, Romoli A, Pancani S, Guido C, Hakiki B. REhabilitation of Dysphagia with ACupuncture and auricular Therapy after severe acquired brain injury (REDACT study): a double-blind randomized controlled trial protocol. Front Neurol. 2026 Feb 24;17:1724043. doi: 10.3389/fneur.2026.1724043. eCollection 2026.
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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.
Bahia Hakiki principal investigator
IRCCS-Fondazione Don Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Auricolotherapy and Conventional logopedic rehabilitation in people with Brain Injury and Cognitive Impairment, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 21 Mar 2025. 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 Italy. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Significant difference measured by Mann Assessment of Swallowing Ability (MASA) Scale (time frame: From enrollment to the end of treatment at 4 weeks and at 3 months). The study lists 2 primary outcomes in all. 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 NCT06888219, which also lists 5 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 21 Mar 2025.