SurvivorshipNCT06610617
Neuromodulation of Central Sensory Integration to Improve Postural Control
A study testing transcranial direct current stimulation (tDCS) in people with Survivorship and Quality of Life, run by University of Pittsburgh at 1 site in United States.
Trial summary
The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Survivorship, Quality of Life, Cognitive Deficits, Mild
- 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 31 Jul 2025
- 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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 50-85 years
- Ability to walk without an assistive device
- Ability to speak and read English
- Without neurological disease
- No history of cancer
- Own a device with capability to sync the Fitbit
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- Inclusion for older, taxane-treated breast, ovarian, and endometrial cancer survivors (OTTBCS) performing a single visit:
- Women aged 50-85 years
- Breast, ovarian and/or endometrial cancer survivors, stages I-IV
- Completion of taxane chemotherapy treatment. Taxane combined with a history of anthracycline and/or cyclophosphamide is permitted. Active anti-estrogen therapy is permitted. Receiving platin based agents is permitted.
- Ability to walk without an assistive device
- Ability to speak and read English
- Without neurological disease, aside from chemotherapy induced peripheral neuropathy (CIPN) or chemotherapy related cognitive dysfunction (CRCD)
- No history of a other cancer, with the exception that non-melanoma skin cancers are permitted
- Own a device with capability to sync the Fitbit
Who cannot join
- Inability to stand or walk unassisted for 60 seconds
- Hospitalization within the past three months due to acute illness or as the result of a musculoskeletal injury significantly affecting gait or balance
- Any unstable medical condition
- Diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder. Cognitive status assessed via the Telephone Interview of Cognitive Status (mTICS). We will exclude those with marked dementia (score<31)
- Chronic vertigo
- Myocardial infarction within the past six months
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- Any history of brain or spine surgery, known hearing, visual, or vestibular impairment
- Active chemotherapy, radiation (see below)
- Currently taking anti-epileptic medication
- Known Brain Metastasis
- Exclusion for older, taxane-treated breast, ovarian, and endometrial cancer survivors (OTTBCS) performing a single visit:
- Inability to stand or walk unassisted for 60 seconds
- Hospitalization within the past three months due to acute illness or as the result of a musculoskeletal injury significantly affecting gait or balance
- Any unstable medical condition
- Diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder. Cognitive status assessed via the Telephone Interview of Cognitive Status (mTICS). We will exclude those with marked dementia (score<31)
- Chronic vertigo
- Myocardial infarction within the past six months
- Known hearing, visual, or vestibular impairment
- Active chemotherapy, radiation (see below)
- Known Brain Metastasis
- Additional Criteria for cancer survivors:
- The following criteria is only exclusionary if participant will receive tDCS. Contraindications to transcranial direct simulation (tDCS), including reported seizure within the past 2 years, Currently taking anti-epileptic medication, active use of neuro-active drugs, metal objects anywhere in the head or the neck, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp. Any history of brain or spine surgery
- Active chemotherapy after the first line of 6 cycles is completed will be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Neuromodulation of Central Sensory Integration to Improve Postural Control: A Pilot Study in Older Women With Breast Cancer
The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.
Read the detailed description
Sensory integration required for balance will be measured using the sensory organization test which includes six conditions in which visual and proprioceptive sensory cues are sequentially referenced (i.e. reduced) to stress available sensory information and sensory integration for postural control. Performance on the sensory organization test has been correlated with falls and successful response to balance perturbation. Balance performance will be evaluated by postural sway. Cognitive function will be assessed using the NIH toolbox with a focus on executive function. tDCS will be used to modify PFC excitability and measure its immediate after-effect on balance performance while performing the sensory organization test in OTTBCS. CIPN severity will be evaluated using measurements of distal proprioception. The study sample will be older breast cancer survivors (n=20) diagnosed and treated with taxane chemotherapy after the age of 60 years to avoid heterogeneity due to multiple cancer types, treatments, and sexes.
Outcome measure were removed. Remaining outcome measures were ones that were assessed both before and after tDCS.
- Conditions
- Survivorship, Quality of Life, Cognitive Deficits, Mild
- Being tested
- transcranial direct current stimulation (tDCS), Sham tDCS
- Medical subject headings
- Cognition Disorders, Lymphoma, Follicular
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
tDCS designed to facilitate the excitability of the left dlPFC or sham stimulation on separate visits separated by at least one week in random order, using a double-blinded, within-subject crossover design. Electrode placement and current parameters will be optimized to each participant with the goal of generating an average electric field of 0.25 V/m within the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA using the Stimweaver algorithm. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort
Sham tDCSDevice
Active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention delivers currents and mimics the sensations induced by tDCS, but does not significantly influence cortical tissue.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS, then Sham tDCS | Experimental | Stimulation (tDCS) will be delivered in visit 2. Sham will be delivered in visit 3. Receives: Device: transcranial direct current stimulation (tDCS); Device: Sham tDCS |
| Sham tDCS, then Active tDCS | Experimental | Sham will be delivered in visit 2. Stimulation (tDCS) will be delivered in visit 3. Receives: Device: transcranial direct current stimulation (tDCS); Device: Sham tDCS |
| No Intervention | No intervention | Participants with a history of cancer and cancer free participants who participated in a single visit without tDCS or sham. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equilibrium Score on Sensory Organization Test
The primary outcome measure of Aim 2 will be the change in composite equilibrium score from before and immediately after a single exposure of tDCS or sham stimulation. Briefly, equilibrium score is assessment of postural sway, which can range from 0 to 100, where a lower score indicates more sway and a zero indicates a fall.
Measured: 8 months
Secondary outcomes (2)
Trail Making B test
To evaluate executive function and processing speed. A higher score is better cognitive function.
Measured: 2 months
Digit Symbol Substitution Test
Test to evaluate executive function and processing speed. A higher score is better cognitive function.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start14 Oct 2024
- Primary completion17 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The interventional study model is a randomized, double-blinded, crossover trial in older taxane treated breast cancer survivors comparing effects of balance between active and sham treatments of a single exposure of transcranial direct current stimulation to the left dorsolateral prefrontal cortex. On 4/2/25, after enrollment of the first 4 cancer survivor participants in the randomized trial, the design was modified to allow cancer survivor participants to opt in or out of the tDCS intervention to compare to the cancer free group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan McNeish, MD, University of Pittsburgh
- Investigators
- Brendan McNeish, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610617
- Sponsor's protocol ID
- STUDY24020169
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The University of Pittsburgh will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, and physiologic data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
Publications
McNeish BL, Richardson JK, Bell SG, Whitney DG. Chemotherapy-induced peripheral neuropathy increases nontraumatic fracture risk in breast cancer survivors. JBMR Plus. 2021 Jun 10;5(8):e10519. doi: 10.1002/jbm4.10519. eCollection 2021 Aug.
PubMed 34368609Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PubMed 25261162Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.
PubMed 28029304Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K. The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.
PubMed 27183099Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
PubMed 28586243Wang AB, Housley SN, Flores AM, Kircher SM, Perreault EJ, Cope TC. A review of movement disorders in chemotherapy-induced neurotoxicity. J Neuroeng Rehabil. 2021 Jan 25;18(1):16. doi: 10.1186/s12984-021-00818-2.
PubMed 33494755Mirelman A, Herman T, Brozgol M, Dorfman M, Sprecher E, Schweiger A, Giladi N, Hausdorff JM. Executive function and falls in older adults: new findings from a five-year prospective study link fall risk to cognition. PLoS One. 2012;7(6):e40297. doi: 10.1371/journal.pone.0040297. Epub 2012 Jun 29.
PubMed 22768271Rosano C, Simonsick EM, Harris TB, Kritchevsky SB, Brach J, Visser M, Yaffe K, Newman AB. Association between physical and cognitive function in healthy elderly: the health, aging and body composition study. Neuroepidemiology. 2005;24(1-2):8-14. doi: 10.1159/000081043.
PubMed 15459503McNeish BL, Dittus K, Mossburg J, Krant N, Steinharter JA, Feb K, Cote H, Hehir MK, Reynolds R, Redfern MS, Rosano C, Richardson JK, Kolb N. Executive function is associated with balance and falls in older cancer survivors treated with chemotherapy: A cross-sectional study. J Geriatr Oncol. 2023 Nov;14(8):101637. doi: 10.1016/j.jgo.2023.101637. Epub 2023 Sep 28.
PubMed 37776612
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Central Sensory Integration to Improve Postural Control: A Pilot Study in Older Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT06610617
- Acronym / sponsor ID
- STUDY24020169
- Conditions
- Survivorship, Quality of Life, Cognitive Deficits, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 24 Sep 2024 (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 objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.
Detailed description
Sensory integration required for balance will be measured using the sensory organization test which includes six conditions in which visual and proprioceptive sensory cues are sequentially referenced (i.e. reduced) to stress available sensory information and sensory integration for postural control. Performance on the sensory organization test has been correlated with falls and successful response to balance perturbation. Balance performance will be evaluated by postural sway. Cognitive function will be assessed using the NIH toolbox with a focus on executive function. tDCS will be used to modify PFC excitability and measure its immediate after-effect on balance performance while performing the sensory organization test in OTTBCS. CIPN severity will be evaluated using measurements of distal proprioception. The study sample will be older breast cancer survivors (n=20) diagnosed and treated with taxane chemotherapy after the age of 60 years to avoid heterogeneity due to multiple cancer types, treatments, and sexes.
Outcome measure were removed. Remaining outcome measures were ones that were assessed both before and after tDCS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The interventional study model is a randomized, double-blinded, crossover trial in older taxane treated breast cancer survivors comparing effects of balance between active and sham treatments of a single exposure of transcranial direct current stimulation to the left dorsolateral prefrontal cortex. On 4/2/25, after enrollment of the first 4 cancer survivor participants in the randomized trial, the design was modified to allow cancer survivor participants to opt in or out of the tDCS intervention to compare to the cancer free group.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS, then Sham tDCS | Experimental | Device: transcranial direct current stimulation (tDCS), Device: Sham tDCSStimulation (tDCS) will be delivered in visit 2. Sham will be delivered in visit 3. |
| Sham tDCS, then Active tDCS | Experimental | Device: transcranial direct current stimulation (tDCS), Device: Sham tDCSSham will be delivered in visit 2. Stimulation (tDCS) will be delivered in visit 3. |
| No Intervention | No intervention | –Participants with a history of cancer and cancer free participants who participated in a single visit without tDCS or sham. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Women aged 50-85 years
- Ability to walk without an assistive device
- Ability to speak and read English
- Without neurological disease
- No history of cancer
Key exclusion criteria (23 listed)
- Inability to stand or walk unassisted for 60 seconds
- Hospitalization within the past three months due to acute illness or as the result of a musculoskeletal injury significantly affecting gait or balance
- Any unstable medical condition
- Diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder. Cognitive status assessed via the Telephone Interview of Cognitive Status (mTICS). We will exclude those with marked dementia (score<31)
- Chronic vertigo
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)tDCS designed to facilitate the excitability of the left dlPFC or sham stimulation on separate visits separated by at least one week in random order, using a double-blinded, within-subject crossover design. Electrode placement and current parameters will be optimized to each participant with the goal of generating an average electric field of 0.25 V/m within the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA using the Stimweaver algorithm. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort | Device | Active tDCS, then Sham tDCS, Sham tDCS, then Active tDCS |
| Sham tDCSActive sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention delivers currents and mimics the sensations induced by tDCS, but does not significantly influence cortical tissue. | Device | Active tDCS, then Sham tDCS, Sham tDCS, then Active tDCS |
Primary outcome
Equilibrium Score on Sensory Organization Test
Time frame: 8 months
The primary outcome measure of Aim 2 will be the change in composite equilibrium score from before and immediately after a single exposure of tDCS or sham stimulation. Briefly, equilibrium score is assessment of postural sway, which can range from 0 to 100, where a lower score indicates more sway and a zero indicates a fall.
2 secondary outcomes
Trail Making B test
Time frame: 2 months
Digit Symbol Substitution Test
Time frame: 2 months
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 12 Nov 2025.
- Background: PubMed 34368609McNeish BL, Richardson JK, Bell SG, Whitney DG. Chemotherapy-induced peripheral neuropathy increases nontraumatic fracture risk in breast cancer survivors. JBMR Plus. 2021 Jun 10;5(8):e10519. doi: 10.1002/jbm4.10519. eCollection 2021 Aug.
- Background: PubMed 25261162Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Background: PubMed 28029304Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.
- Background: PubMed 27183099Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K. The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.
- Background: PubMed 28586243Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
- Background: PubMed 33494755Wang AB, Housley SN, Flores AM, Kircher SM, Perreault EJ, Cope TC. A review of movement disorders in chemotherapy-induced neurotoxicity. J Neuroeng Rehabil. 2021 Jan 25;18(1):16. doi: 10.1186/s12984-021-00818-2.
- Background: PubMed 22768271Mirelman A, Herman T, Brozgol M, Dorfman M, Sprecher E, Schweiger A, Giladi N, Hausdorff JM. Executive function and falls in older adults: new findings from a five-year prospective study link fall risk to cognition. PLoS One. 2012;7(6):e40297. doi: 10.1371/journal.pone.0040297. Epub 2012 Jun 29.
- Background: PubMed 15459503Rosano C, Simonsick EM, Harris TB, Kritchevsky SB, Brach J, Visser M, Yaffe K, Newman AB. Association between physical and cognitive function in healthy elderly: the health, aging and body composition study. Neuroepidemiology. 2005;24(1-2):8-14. doi: 10.1159/000081043.
- Background: PubMed 37776612McNeish BL, Dittus K, Mossburg J, Krant N, Steinharter JA, Feb K, Cote H, Hehir MK, Reynolds R, Redfern MS, Rosano C, Richardson JK, Kolb N. Executive function is associated with balance and falls in older cancer survivors treated with chemotherapy: A cross-sectional study. J Geriatr Oncol. 2023 Nov;14(8):101637. doi: 10.1016/j.jgo.2023.101637. Epub 2023 Sep 28.
- The Effect of Chemotherapy on Balance, Gait, and Falls Among Cancer Survivors: A Scoping ReviewLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The University of Pittsburgh will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, and physiologic data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
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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.
Brendan McNeish, MD principal investigator
University of Pittsburgh
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 Survivorship and Quality of Life, run by University of Pittsburgh at 1 site in United States.
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 15 inclusion and 23 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 12 Nov 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 United States. 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?
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?
Equilibrium Score on Sensory Organization Test (time frame: 8 months). 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 NCT06610617, which also lists 9 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 12 Nov 2025.