Subjective Cognitive Decline (SCD)NCT07350226
Electro-acupuncture for SCD With Depression
A study testing "TXJN" electro-acupuncture in people with Subjective Cognitive Decline (SCD) and Depression Disorder, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of electroacupuncture in treating adults with subjective cognitive decline accompanied by depression. The main objectives are to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Subjective Cognitive Decline (SCD), Depression Disorder
- What is being tested?
- "TXJN" electro-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Jul 2027
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-80 years, right-handed
- Meets the diagnostic criteria for Subjective Cognitive Decline (SCD)
- Geriatric Depression Scale-15 (GDS-15) score ≥5
- Clear consciousness, cooperative during examination, with adequate auditory comprehension
- Patient and family agree to complete assessments and have provided informed consent with signed documentation
Who cannot join
- Received other anti-dementia or antidepressant therapy within the past 2 weeks, or currently participating in other clinical trials
- Experienced acute cerebral infarction, cerebral hemorrhage, or transient ischemic symptoms within the past 6 months, or presence of localized old encephalomalacia foci
- History of positive neuropsychiatric disorders and major trauma, including dementia, depression, epilepsy, etc.
- Suffering from other severe comorbidities (aphasia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, diabetic lower limb vascular disease, moderate to severe edema of lower limbs, lower limb venous thrombosis, arteriosclerosis obliterans of lower limbs, peripheral neuropathy, spinal cord lesions, traumatic brain injury, intracranial infection, brain tumors, etc.) or secondary diseases (e.g., heart, liver, or renal failure, etc.)
- Infection at the acupuncture site and/or intolerance to acupuncture therapy
- Contraindications to MRI examination (claustrophobia, surgically implanted metal devices, cochlear implants, implanted pulse generators, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: Efficacy and Amygdala-entorhinal Circuit of Electroacupuncture Intervention in SCD With Depression: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the efficacy and safety of electroacupuncture in treating adults with subjective cognitive decline accompanied by depression. The main objectives are to answer the following questions:
- Can electroacupuncture improve cognitive function and depressive symptoms in individuals with subjective cognitive decline accompanied by depression?
- Does electroacupuncture alleviate subjective cognitive decline with depression by modulating the amygdala-entorhinal circuit, and if so, what is the specific mechanism involved? Researchers will compare real electroacupuncture therapy with sham electroacupuncture therapy to determine whether real electroacupuncture can effectively improve symptoms in patients with subjective cognitive decline accompanied by depression. Additionally, multimodal magnetic resonance imaging (MRI) technology will be used to assess changes in the amygdala-entorhinal circuit following electroacupuncture intervention.
Read more
Participants will:
- Receive either real or sham electroacupuncture treatment once daily, 3-5 times per week, for a total treatment duration of 8 weeks.
- Undergo cognitive function and depression assessments before and after treatment.
- Complete multimodal cranial magnetic resonance imaging examinations before and after treatment.
- Being tested
- "TXJN" electro-acupuncture, Sham electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"TXJN" electro-acupunctureDevice
Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.
The selected acupoints included bilateral Neiguan (PC6), Yintang (EX-HN3), bilateral Yingxiang (LI20), Shenting (GV24), Baihui (GV20), and Sishencong (EX-HN1).After achieving the deqi sensation through acupuncture manipulation, electroacupuncture (SDZ-V, Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.) was applied. The treatment utilized a dense-disperse wave at a frequency of 2 Hz, with a current intensity of 2-4 mA adjusted to the patient's tolerance level. The needles were retained for 30 minutes.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks.
Sham electroacupunctureDevice
Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.Acupoints were selected at 0.2-0.4 cun (5-10 mm) lateral to the original acupoints of the experimental group. The needles were inserted shallowly at a depth of 0.2-0.3 cun (5-8 mm), without eliciting the deqi sensation. The same electroacupuncture device was connected but with no electrical output. The needles were retained for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | "TXJN" electro-acupuncture：Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.The selected acupoints included bilateral Neiguan (PC6), Yintang (EX-HN3), bilateral Yingxiang (LI20), Shenting (GV24), Baihui (GV20), and Sishencong (EX-HN1).After achieving the deqi sensation through acupuncture manipulation, electroacupuncture (SDZ-V, Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.) was applied. The treatment utilized a dense-disperse wave at a frequency of 2 Hz, with a current intensity of 2-4 mA adjusted to the patient's tolerance level. The needles were retained for 30 minutes.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks. Receives: Device: "TXJN" electro-acupuncture |
| Control group | Sham comparator | Sham electroacupuncture: Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.Acupoints were selected at 0.2-0.4 cun (5-10 mm) lateral to the original acupoints of the experimental group. The needles were inserted shallowly at a depth of 0.2-0.3 cun (5-8 mm), without eliciting the deqi sensation. The same electroacupuncture device was connected but with no electrical output. The needles were retained for 30 minutes.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks. Receives: Device: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Cognitive Z-Score
This composite index of global cognitive function is derived from the aggregated Z-scores of eight neuropsychological tests (including Auditory Verbal Learning Test, Animal Fluency Test, Boston Naming Test, Trail Making Test Parts A/B, Stroop Color-Word Test-Card C, Digit Symbol Substitution Test, Digit Span Test, and Clock Drawing Test). At baseline, each test's raw scores will be standardized using the study population's mean and standard deviation (Z = [raw score - mean]/SD). For tests where lower scores indicate better performance (e.g., Trail Making Test time), Z-scores are reversed (multiplied by -1) to align directionality. The final aggregated Z-score, expressed in standard deviation units, will be assessed pre-treatment and 8 weeks post-treatment initiation.
Measured: Before and 8 weeks after treatment
Geriatric Depression Scale 15-Item (GDS-15) Reduction Rate
The reduction rate is calculated based on the total score (range: 0-15, where a higher score indicates more severe depressive symptoms) of the 15-item Geriatric Depression Scale. The reduction rate formula is: ([Pre-treatment score - Post-treatment score] / Pre-treatment score) × 100%. Efficacy is defined as: Markedly Effective (reduction rate ≥ 50%); Effective (50% > reduction rate ≥ 25%); Ineffective (reduction rate < 25%).
Measured: Before and 8 weeks after treatment
Multimodal magnetic resonance imaging indicators
sMRI indicators: GMV, FA, MD; rs-fMRI indicators: ALFF, fALFF, ReHo, Seed-based FC.
Measured: Before and 8 weeks after treatment
Secondary outcomes (12)
Mini-Mental State Examination (MMSE) Total Score
The total score (range: 0-30) of the Mini-Mental State Examination, where a higher score indicates better cognitive function.
Measured: Before and 8 weeks after treatment
Auditory Verbal Learning Test (AVLT) Long-Delay Free Recall Score
The score for the long-delay free recall trial of the Auditory Verbal Learning Test (range: 0-15 words), where a higher score indicates better episodic memory function.
Measured: Before and 8 weeks after treatment
Rey-Osterrieth Complex Figure Test (ROCF) Delayed Recall Score
The score for the delayed recall trial of the Rey-Osterrieth Complex Figure Test, which is typically scored on a standardized system (e.g., 0-36 points based on accuracy and placement of reproduced elements), where a higher score indicates better visual-spatial memory and recall ability.
Measured: Before and 8 weeks after treatment
Boston Naming Test (BNT) Total Correct Score
The total number of correctly named items (range: 0-30) of the 30-item Boston Naming Test, where a higher score indicates better confrontational word retrieval and language ability.
Measured: Before and 8 weeks after treatment
Animal Fluency Test (AFT) Total Score
The total number of correct, unique animal names generated within 60 seconds (common score range: 0-50+), where a higher score indicates better semantic verbal fluency and executive functioning.
Measured: Before and 8 weeks after treatment
Trail Making Test Part A (TMT-A) Completion Time
The time to completion (in seconds) for Trail Making Test Part A, where a shorter completion time indicates better visual attention, processing speed, and motor function.
Measured: Before and 8 weeks after treatment
Trail Making Test Part B (TMT-B) Completion Time
The time to completion (in seconds) for Trail Making Test Part B, where a shorter completion time indicates better cognitive flexibility, task-switching ability, and executive function.
Measured: Before and 8 weeks after treatment
Clock Drawing Test (CDT) Total Score
The total score on the standardized 30-point Clock Drawing Test (CDT30-AJ/CI version, range: 0-30), where a higher score indicates better visuospatial/executive function and cognitive integrity.
Measured: Before and 8 weeks after treatment
Symbol Digit Modalities Test (SDMT) Correct Response Count
The total number of correct symbol-digit pairings completed within 90 seconds (common score range: 0-110+), where a higher score indicates better processing speed, sustained attention, and visual scanning.
Measured: Before and 8 weeks after treatment
Pittsburgh Sleep Quality Index (PSQI) Global Score
The global score (range: 0-21) of the Pittsburgh Sleep Quality Index, where a higher score indicates poorer sleep quality.
Measured: Before and 8 weeks after treatment
TCM Constitution Classification and Determination Scale - Transformed Scores
The transformed scores (range: 0-100 for each of the nine constitution subscales) calculated according to the standardized "TCM Constitution Classification and Determination Scale" (published by the China Association of Chinese Medicine). A higher transformed score on a specific subscale indicates a more pronounced tendency towards that constitution type (e.g., Yang Deficiency, Qi Deficiency, etc.).
Measured: Before and 8 weeks after treatment
TCM Syndrome Type Scale for Mild Cognitive Impairment Subscale Scores
Scores (range: 0-30 per syndrome) for seven TCM syndrome types (e.g., Spleen-Kidney Deficiency) as assessed by the standardized "TCM Syndrome Type Scale for Mild Cognitive Impairment", where a higher score indicates more severe syndrome manifestation.
Measured: Before and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Oct 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive Decline (SCD)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350226
- Sponsor's protocol ID
- JSTJ-2024-381
- Status last verified
- Sep 2025
- First submitted
- 11 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Amygdala-entorhinal Circuit of Electroacupuncture Intervention in SCD With Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07350226
- Acronym / sponsor ID
- JSTJ-2024-381
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Jan 2026 (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 clinical trial is to evaluate the efficacy and safety of electroacupuncture in treating adults with subjective cognitive decline accompanied by depression. The main objectives are to answer the following questions:
- Can electroacupuncture improve cognitive function and depressive symptoms in individuals with subjective cognitive decline accompanied by depression?
- Does electroacupuncture alleviate subjective cognitive decline with depression by modulating the amygdala-entorhinal circuit, and if so, what is the specific mechanism involved? Researchers will compare real electroacupuncture therapy with sham electroacupuncture therapy to determine whether real electroacupuncture can effectively improve symptoms in patients with subjective cognitive decline accompanied by depression. Additionally, multimodal magnetic resonance imaging (MRI) technology will be used to assess changes in the amygdala-entorhinal circuit following electroacupuncture intervention.
Participants will:
- Receive either real or sham electroacupuncture treatment once daily, 3-5 times per week, for a total treatment duration of 8 weeks.
- Undergo cognitive function and depression assessments before and after treatment.
- Complete multimodal cranial magnetic resonance imaging examinations before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Device: "TXJN" electro-acupuncture"TXJN" electro-acupuncture：Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.The selected acupoints included bilateral Neiguan (PC6), Yintang (EX-HN3), bilateral Yingxiang (LI20), Shenting (GV24), Baihui (GV20), and Sishencong (EX-HN1).After achieving the deqi sensation through acupuncture manipulation, electroacupuncture (SDZ-V, Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.) was applied. The treatment utilized a dense-disperse wave at a frequency of 2 Hz, with a current intensity of 2-4 mA adjusted to the patient's tolerance level. The needles were retained for 30 minutes.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks. |
| Control group | Sham comparator | Device: Sham electroacupunctureSham electroacupuncture: Disposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.Acupoints were selected at 0.2-0.4 cun (5-10 mm) lateral to the original acupoints of the experimental group. The needles were inserted shallowly at a depth of 0.2-0.3 cun (5-8 mm), without eliciting the deqi sensation. The same electroacupuncture device was connected but with no electrical output. The needles were retained for 30 minutes.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60-80 years, right-handed
- Meets the diagnostic criteria for Subjective Cognitive Decline (SCD)
- Geriatric Depression Scale-15 (GDS-15) score ≥5
- Clear consciousness, cooperative during examination, with adequate auditory comprehension
- Patient and family agree to complete assessments and have provided informed consent with signed documentation
Key exclusion criteria (6 listed)
- Received other anti-dementia or antidepressant therapy within the past 2 weeks, or currently participating in other clinical trials
- Experienced acute cerebral infarction, cerebral hemorrhage, or transient ischemic symptoms within the past 6 months, or presence of localized old encephalomalacia foci
- History of positive neuropsychiatric disorders and major trauma, including dementia, depression, epilepsy, etc.
- Suffering from other severe comorbidities (aphasia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, diabetic lower limb vascular disease, moderate to severe edema of lower limbs, lower limb venous thrombosis, arteriosclerosis obliterans of lower limbs, peripheral neuropathy, spinal cord lesions, traumatic brain injury, intracranial infection, brain tumors, etc.) or secondary diseases (e.g., heart, liver, or renal failure, etc.)
- Infection at the acupuncture site and/or intolerance to acupuncture therapy
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 |
|---|---|---|
| "TXJN" electro-acupunctureDisposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used. The selected acupoints included bilateral Neiguan (PC6), Yintang (EX-HN3), bilateral Yingxiang (LI20), Shenting (GV24), Baihui (GV20), and Sishencong (EX-HN1).After achieving the deqi sensation through acupuncture manipulation, electroacupuncture (SDZ-V, Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd.) was applied. The treatment utilized a dense-disperse wave at a frequency of 2 Hz, with a current intensity of 2-4 mA adjusted to the patient's tolerance level. The needles were retained for 30 minutes.The treatment was administered once daily, 3-5 times per week, for a total duration of 8 weeks. | Device | Experiment group |
| Sham electroacupunctureDisposable acupuncture needles (Huatuo brand, Suzhou Medical Supplies Factory Co., Ltd., specification: 0.25 mm × 40 mm) were used.Acupoints were selected at 0.2-0.4 cun (5-10 mm) lateral to the original acupoints of the experimental group. The needles were inserted shallowly at a depth of 0.2-0.3 cun (5-8 mm), without eliciting the deqi sensation. The same electroacupuncture device was connected but with no electrical output. The needles were retained for 30 minutes. | Device | Control group |
Primary outcome
Comprehensive Cognitive Z-Score
Time frame: Before and 8 weeks after treatment
This composite index of global cognitive function is derived from the aggregated Z-scores of eight neuropsychological tests (including Auditory Verbal Learning Test, Animal Fluency Test, Boston Naming Test, Trail Making Test Parts A/B, Stroop Color-Word Test-Card C, Digit Symbol Substitution Test, Digit Span Test, and Clock Drawing Test). At baseline, each test's raw scores will be standardized using the study population's mean and standard deviation (Z = [raw score - mean]/SD). For tests where lower scores indicate better performance (e.g., Trail Making Test time), Z-scores are reversed (multiplied by -1) to align directionality. The final aggregated Z-score, expressed in standard deviation units, will be assessed pre-treatment and 8 weeks post-treatment initiation.
Geriatric Depression Scale 15-Item (GDS-15) Reduction Rate
Time frame: Before and 8 weeks after treatment
The reduction rate is calculated based on the total score (range: 0-15, where a higher score indicates more severe depressive symptoms) of the 15-item Geriatric Depression Scale. The reduction rate formula is: ([Pre-treatment score - Post-treatment score] / Pre-treatment score) × 100%. Efficacy is defined as: Markedly Effective (reduction rate ≥ 50%); Effective (50% > reduction rate ≥ 25%); Ineffective (reduction rate < 25%).
Multimodal magnetic resonance imaging indicators
Time frame: Before and 8 weeks after treatment
sMRI indicators: GMV, FA, MD; rs-fMRI indicators: ALFF, fALFF, ReHo, Seed-based FC.
12 secondary outcomes
Mini-Mental State Examination (MMSE) Total Score
Time frame: Before and 8 weeks after treatment
Auditory Verbal Learning Test (AVLT) Long-Delay Free Recall Score
Time frame: Before and 8 weeks after treatment
Rey-Osterrieth Complex Figure Test (ROCF) Delayed Recall Score
Time frame: Before and 8 weeks after treatment
Boston Naming Test (BNT) Total Correct Score
Time frame: Before and 8 weeks after treatment
Animal Fluency Test (AFT) Total Score
Time frame: Before and 8 weeks after treatment
Trail Making Test Part A (TMT-A) Completion Time
Time frame: Before and 8 weeks after treatment
Trail Making Test Part B (TMT-B) Completion Time
Time frame: Before and 8 weeks after treatment
Clock Drawing Test (CDT) Total Score
Time frame: Before and 8 weeks after treatment
Symbol Digit Modalities Test (SDMT) Correct Response Count
Time frame: Before and 8 weeks after treatment
Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Before and 8 weeks after treatment
TCM Constitution Classification and Determination Scale - Transformed Scores
Time frame: Before and 8 weeks after treatment
TCM Syndrome Type Scale for Mild Cognitive Impairment Subscale Scores
Time frame: Before and 8 weeks after treatment
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 20 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "TXJN" electro-acupuncture in people with Subjective Cognitive Decline (SCD) and Depression Disorder, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. 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 China. 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?
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?
Comprehensive Cognitive Z-Score (time frame: Before and 8 weeks after treatment). The study lists 3 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 20 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.