Functional Constipation (FC)RELIEF-tACSNCT07323407
Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder
A study testing Transcranial Alternating Current Stimulation in people with Functional Constipation (FC) and Somatic Symptom Disorder (DSM-5), run by Xijing Hospital of Digestive Diseases at 2 sites in China.
Trial summary
The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Constipation (FC), Somatic Symptom Disorder (DSM-5), Refractory Constipation
- What is being tested?
- Transcranial Alternating Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 20 Aug 2025to 1 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Functional Constipation (FC): Subjects must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.
- Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, subjects must have ≤2 complete spontaneous bowel movements per week.
- Poor Response to Previous Treatment: Subjects must have been dissatisfied with prior treatments for functional constipation and have undergone at least 3 months of therapy (including laxatives or other prokinetic agents).
- Diagnosis of Somatic Symptom Disorder (SSD): Subjects must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All subjects will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.
- Criterion A: Presence of one or more distressing somatic symptoms that significantly affect daily life.
- Criterion B: At least one of the following must be met:
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- Excessive and persistent thoughts about the severity of symptoms;
- Persistently high levels of anxiety about health or symptoms;
- Excessive time and energy devoted to health concerns or symptoms.
- Criterion C: Symptoms must persist for at least 6 months.
- Age Range: Subjects must be between 18 and 80 years old.
- No Concurrent Clinical Trials: Subjects must not participate in any other clinical trials during the study period.
- Informed Consent: Subjects must voluntarily agree to participate and sign an informed consent form.
Who cannot join
- Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g., hypothyroidism), metabolic diseases (diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease);
- Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives, antidiarrheals, or intestinal stimulants; during the trial, participants are only allowed to take prescribed emergency medications, with detailed records of usage required);
- History of chronic pain or substance abuse, such as opioids;
- Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication use for over 3 months;
- Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;
- History of allergy to psychiatric medications (e.g., fluoxetine), or contraindications to fluoxetine such as liver/kidney impairment or prolonged Q-T interval on ECG;
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- Pregnant or breastfeeding women;
- Patients with benign or malignant tumors or autoimmune diseases;
- Chronic conditions requiring long-term medication that may affect quality of life or interfere with examinations/treatment, including cardiovascular diseases, coagulation disorders or regular anticoagulant use (warfarin/heparin), liver/kidney diseases, organ failure, cognitive impairment, aphasia, etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710032
Qinxian Huang, 18192210687, qinxianhuang2022@163.com
yangbin8072@126.com
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Zhifeng Zhao, Dr., +8613519171072, zhaozhifeng@outlook.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Transcranial Alternating Current Stimulation (tACS) for the Treatment of Refractory Constipation Comorbid With Somatic Symptom Disorder
The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. This population is characterized by persistent bowel dysfunction despite conventional treatments, frequent reliance on laxatives, and evidence of impaired brain-gut regulation contributing to chronic symptoms.
The study focuses on three primary domains:
Read more
Efficacy - Bowel Function:
- Assessment of whether a 4-week course of tACS improves bowel activity, measured by changes in Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency over the treatment and follow-up period.
Efficacy - Symptom and Quality of Life Burden:
- Evaluation of the effect of tACS on constipation-related severity and patient-reported outcomes, including the Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL).
Safety and Tolerability:
- Documentation of adverse events associated with tACS, with particular attention to incidence, intensity, and overall patient tolerability compared with sham stimulation.
- Being tested
- Transcranial Alternating Current Stimulation, Placebo
- Keywords
- Functional Constipation, Somatic Symptom Disorder, refractory constipation, transcranial alternating current stimulation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current StimulationDevice
Electrode placement: Referenced to the forehead (Fpz) and bilateral mastoid regions, covering the prefrontal cortex and related brain-gut axis pathways.
Stimulation parameters: Alternating current, 15 mA intensity, 77.5 Hz frequency.
Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks).
PlaceboDevice
Electrode placement: Same as active-referenced to the forehead (Fpz) and bilateral mastoid regions, to mimic coverage of the prefrontal cortex and related brain-gut axis pathways.
Stimulation parameters: Sham stimulation; the device is programmed to deliver a brief ramp-up and ramp-down at session start (e.g., ≤30 seconds total) to reproduce initial skin sensations, followed by no sustained current (0 mA effective intensity; no therapeutic stimulation).
Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks).
Blinding procedures: Device display, sounds, and electrode preparation identical to the active arm; session duration and operator interactions matched to maintain participant and assessor blinding.
| Study group | Role | What they receive |
|---|---|---|
| tACS | Experimental | Electrode placement: Referenced to the forehead (Fpz) and bilateral mastoid regions, covering the prefrontal cortex and related brain-gut axis pathways.
Stimulation parameters: Alternating current, 15 mA intensity, 77.5 Hz frequency.
Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks). Receives: Device: Transcranial Alternating Current Stimulation |
| Placebo | Placebo comparator | Electrode placement: Same as active-referenced to the forehead (Fpz) and bilateral mastoid regions, to mimic coverage of the prefrontal cortex and related brain-gut axis pathways.
Stimulation parameters: Sham stimulation; the device is programmed to deliver a brief ramp-up and ramp-down at session start (e.g., ≤30 seconds total) to reproduce initial skin sensations, followed by no sustained current (0 mA effective intensity; no therapeutic stimulation).
Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks).
Blinding procedures: Device display, sounds, and electrode preparation identical to the active arm; session duration and operator interactions matched to maintain participant and assessor blinding. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion (%) of patients who achieved an increase of ≥1 CSBM per week compared to baseline for at least 2 out of the 4 treatment weeks.
Measured: 1-4 treatment week
Secondary outcomes (11)
Proportion of participants achieving an increase of ≥1 CSBM from baseline in at least 2 weeks during follow-up
Measured: Weeks 1-4 follow-up; assessed over the 4-week period
Change from baseline in weekly frequency of spontaneous bowel movements (SBM)
Measured: Baseline and each week during Weeks 1-4
Change from baseline in weekly frequency of complete spontaneous bowel movements (CSBM)
Measured: Baseline and each week during Weeks 1-4
Change from baseline in stool consistency (Bristol Stool Form Scale) for weekly SBMs
Measured: Baseline and Weeks 3-4
Change from baseline in straining score for weekly SBMs (4-point scale: 0=no difficulty, 1=mild, 2=moderate, 3=severe)
Measured: Baseline and Weeks 3-4
Change from baseline in abdominal bloating severity (5-point scale: 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe)
Measured: Baseline and Weeks 3-4
Change from baseline in Patient Health Questionnaire-9 (PHQ-9) score
Measured: Baseline and Week 4
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) score
Measured: Baseline and Week 4
Change from baseline in Patient Health Questionnaire-15 (PHQ-15) somatic symptom score
Measured: Baseline and Week 4
Change from baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL)
Measured: Baseline and Week 4
Proportion of participants using polyethylene glycol (PEG) as rescue medication
Measured: During the 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start20 Aug 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)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
- Model description
- This study uses a randomized, double-blind, placebo-controlled "Parallel Assignment" design with two arms: Experimental Arm - transcranial alternating current stimulation (tACS) Control Arm - Matching Placebo Participants are assigned in a 1 : 1 ratio by a central interactive web-response system, using permuted blocks stratified by study center and baseline CSBM frequency. Each participant receives only one intervention for the entire 4-week treatment period (plus taper/follow-up), with no crossover between arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Zhao, PhD, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323407
- Sponsor's protocol ID
- XJLL-KY-20252521
- Acronym
- RELIEF-tACS
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhaozhifeng@outlook.com.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Transcranial Alternating Current Stimulation (tACS) for the Treatment of Refractory Constipation Comorbid With Somatic Symptom Disorder
- ClinicalTrials.gov ID
- NCT07323407
- Acronym / sponsor ID
- RELIEF-tACS / XJLL-KY-20252521
- Keywords
- Functional Constipation, Somatic Symptom Disorder, refractory constipation, transcranial alternating current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 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 purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. This population is characterized by persistent bowel dysfunction despite conventional treatments, frequent reliance on laxatives, and evidence of impaired brain-gut regulation contributing to chronic symptoms.
The study focuses on three primary domains:
Efficacy - Bowel Function:
- Assessment of whether a 4-week course of tACS improves bowel activity, measured by changes in Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency over the treatment and follow-up period.
Efficacy - Symptom and Quality of Life Burden:
- Evaluation of the effect of tACS on constipation-related severity and patient-reported outcomes, including the Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL).
Safety and Tolerability:
- Documentation of adverse events associated with tACS, with particular attention to incidence, intensity, and overall patient tolerability compared with sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized, double-blind, placebo-controlled "Parallel Assignment" design with two arms: Experimental Arm - transcranial alternating current stimulation (tACS) Control Arm - Matching Placebo Participants are assigned in a 1 : 1 ratio by a central interactive web-response system, using permuted blocks stratified by study center and baseline CSBM frequency. Each participant receives only one intervention for the entire 4-week treatment period (plus taper/follow-up), with no crossover between arms.
| Arm | Type | Receives |
|---|---|---|
| tACS | Experimental | Device: Transcranial Alternating Current StimulationElectrode placement: Referenced to the forehead (Fpz) and bilateral mastoid regions, covering the prefrontal cortex and related brain-gut axis pathways. Stimulation parameters: Alternating current, 15 mA intensity, 77.5 Hz frequency. Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks). |
| Placebo | Placebo comparator | Device: PlaceboElectrode placement: Same as active-referenced to the forehead (Fpz) and bilateral mastoid regions, to mimic coverage of the prefrontal cortex and related brain-gut axis pathways. Stimulation parameters: Sham stimulation; the device is programmed to deliver a brief ramp-up and ramp-down at session start (e.g., ≤30 seconds total) to reproduce initial skin sensations, followed by no sustained current (0 mA effective intensity; no therapeutic stimulation). Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks). Blinding procedures: Device display, sounds, and electrode preparation identical to the active arm; session duration and operator interactions matched to maintain participant and assessor blinding. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of Functional Constipation (FC): Subjects must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.
- Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, subjects must have ≤2 complete spontaneous bowel movements per week.
- Poor Response to Previous Treatment: Subjects must have been dissatisfied with prior treatments for functional constipation and have undergone at least 3 months of therapy (including laxatives or other prokinetic agents).
- Diagnosis of Somatic Symptom Disorder (SSD): Subjects must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All subjects will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.
- Age Range: Subjects must be between 18 and 80 years old.
Key exclusion criteria (9 listed)
- Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g., hypothyroidism), metabolic diseases (diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease);
- Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives, antidiarrheals, or intestinal stimulants; during the trial, participants are only allowed to take prescribed emergency medications, with detailed records of usage required);
- History of chronic pain or substance abuse, such as opioids;
- Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication use for over 3 months;
- Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;
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 Alternating Current StimulationElectrode placement: Referenced to the forehead (Fpz) and bilateral mastoid regions, covering the prefrontal cortex and related brain-gut axis pathways. Stimulation parameters: Alternating current, 15 mA intensity, 77.5 Hz frequency. Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks). | Device | tACS |
| PlaceboElectrode placement: Same as active-referenced to the forehead (Fpz) and bilateral mastoid regions, to mimic coverage of the prefrontal cortex and related brain-gut axis pathways. Stimulation parameters: Sham stimulation; the device is programmed to deliver a brief ramp-up and ramp-down at session start (e.g., ≤30 seconds total) to reproduce initial skin sensations, followed by no sustained current (0 mA effective intensity; no therapeutic stimulation). Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks). Blinding procedures: Device display, sounds, and electrode preparation identical to the active arm; session duration and operator interactions matched to maintain participant and assessor blinding. | Device | Placebo |
Primary outcome
The proportion (%) of patients who achieved an increase of ≥1 CSBM per week compared to baseline for at least 2 out of the 4 treatment weeks.
Time frame: 1-4 treatment week
11 secondary outcomes
Proportion of participants achieving an increase of ≥1 CSBM from baseline in at least 2 weeks during follow-up
Time frame: Weeks 1-4 follow-up; assessed over the 4-week period
Change from baseline in weekly frequency of spontaneous bowel movements (SBM)
Time frame: Baseline and each week during Weeks 1-4
Change from baseline in weekly frequency of complete spontaneous bowel movements (CSBM)
Time frame: Baseline and each week during Weeks 1-4
Change from baseline in stool consistency (Bristol Stool Form Scale) for weekly SBMs
Time frame: Baseline and Weeks 3-4
Change from baseline in straining score for weekly SBMs (4-point scale: 0=no difficulty, 1=mild, 2=moderate, 3=severe)
Time frame: Baseline and Weeks 3-4
Change from baseline in abdominal bloating severity (5-point scale: 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe)
Time frame: Baseline and Weeks 3-4
Change from baseline in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline and Week 4
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline and Week 4
Change from baseline in Patient Health Questionnaire-15 (PHQ-15) somatic symptom score
Time frame: Baseline and Week 4
Change from baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL)
Time frame: Baseline and Week 4
Proportion of participants using polyethylene glycol (PEG) as rescue medication
Time frame: During the 4-week treatment period
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 9 Jan 2026.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhaozhifeng@outlook.com.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation in people with Functional Constipation (FC) and Somatic Symptom Disorder (DSM-5), run by Xijing Hospital of Digestive Diseases at 2 sites 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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 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 2 sites 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?
Contact Zhifeng Zhao, Dr. (+8613519171072, zhaozhifeng@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion (%) of patients who achieved an increase of ≥1 CSBM per week compared to baseline for at least 2 out of the 4 treatment weeks. (time frame: 1-4 treatment week). 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 9 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.