Post-stroke DepressionNCT03903068
Transcranial Alternating Current Stimulation Treating Post-stroke Depression
A study testing NEXALIN ADI AC stimulator and Pseudo-stimulator in people with Post-stroke Depression, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Post-stroke depression (PSD) is one of the most common complications after stroke, with a high prevalence. PSD can affect prognosis and rehabilitation of stroke, increase risks of mortality and suicide, and escalate the economic burden on individuals and society. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- NEXALIN ADI AC stimulator and Pseudo-stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of PSD is based on the "Depressive disorder due to another medical condition" of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
- Age 18-70 years old, gender is not limited;
- Right-handed;
- More than 6 months after the onset of stroke;
- The duration of depressive disorder persists for more than two weeks;
- Having the Hamilton Depression Rating Scale 17-Item (HAMD-17) scores higher than 17 at baseline;
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- Absence of psychiatric disorder or family history of psychosis before stroke;
- Has never taken antidepressants before enrollment;
- Having the level of audiovisual for examinations required for the study;
- Providing signed informed consent.
Who cannot join
- Patients with life expectancy < 6 months;
- Severe or unstable organic diseases;
- Acute brain injury and infection;
- The impaired skin integrity at the electrode placement site or skin allergic to electrode gel or adhesive;
- Active current suicidal intent or plan as shown by a score of ≥ 3 on the suicide item of HAMD-17;
- Current participation in any other clinical trial,;
Show all 10Show fewer
- Prior exposure to all kinds of neuromodulation treatments (including electroconvulsive therapy, TMS, tDCS, etc);
- Prior exposure to any implanted device in body (including a cochlear implant, cardiac pacemaker, an implanted device or metal in the brain);
- A history of brain organic diseases (including seizures, hydrocephalus, and brain tumors);
- Any situations the investigators believe that they are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Haiqing Song, Doctor
About this study
Official title: The Efficacy of Transcranial Alternating Current Stimulation for Treating Post-stroke Depression: a Randomized Controlled Trial
Post-stroke depression (PSD) is one of the most common complications after stroke, with a high prevalence. PSD can affect prognosis and rehabilitation of stroke, increase risks of mortality and suicide, and escalate the economic burden on individuals and society. Studies have shown that transcranial alternating current stimulation (tACS) can also be used to treat depression, insomnia and anxiety. So far, this stimulator has been approved by FDA. However, there have not been any reports on the use of tACS in the treatment of depression and PSD in China. In this trial, the efficacy and safety of the tACS will be assessed with the rigor methodology manner.
Read the detailed description
Patients with post-stroke depression (PSD) have more dysfunction, poorer recovery outcomes, and higher morbidity and mortality in the first year after stroke onset than those patients without stroke. Some therapeutic methods have shown to be effective for PSD, including antidepressants, non-drug interventions, and combination therapies. However, pharmacological agents not only show unwanted side effects, including nausea, diarrhea, fatigue, and dizziness, but also produce high risk of hemorrhagic complications and stroke. Therefore, in addition to antidepressants treating PSD, non-drug interventions have been proposed to treat PSD. Until now, there are various physical techniques, including transcranial magnetic stimulation, vagus nerve stimulation, transcranial direct current stimulation, transcranial ultrasonic stimulation, etc. Previous studies have shown that transcranial alternating current stimulation (tACS) is commonly used to relieve pain, and has also been used to treat conditions such as transient tic disorder and cluster headaches. In the brain, there are specific opioid receptors which are not independent, and they work together with the electro analgesic system. Patients treated for chronic pain had lower levels of endorphins in their cerebrospinal fluid. Theoretically, using tACS can alleviate pain was caused by electrical stimulation to activate the brain's pain system (anti-nociceptive system), led to the beta-endorphin, serotonin and norepinephrine release.
Therefore, the study is expected to verify the effect of Transcranial Alternating Current Stimulation on patients with PSD in China and preliminarily explore the variations of gamma and beta-oscillations and cognitive function for the intervention of PSD utilized by it.
- Conditions
- Post-stroke Depression
- Being tested
- NEXALIN ADI AC stimulator, Pseudo-stimulator
- Keywords
- transcranial alternating current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEXALIN ADI AC stimulatorDevice
When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. The three electrodes are placed in this way to enhance the performance of the Nexalin ADI device. When the device is activated, there will be a weak current passing through the forehead electrode and each mastoid electrode. The current intensity of Nexalin ADI treatment defaults to 15.00 mA and the duration defaults to 40 minutes. Both are preset to default parameters and cannot be changed.
Pseudo-stimulatorDevice
When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. When the device is started, no current flows through the electrodes, but the instrument's operating procedures, parameter displays, and prompts are the same as for a real instrument.
| Study group | Role | What they receive |
|---|---|---|
| NEXALIN Stimulator Group | Experimental | In this study, the group is the treatment group. Patients are randomly assigned to participate, and patients will be given current parameters for setting time and flow. Receives: Device: NEXALIN ADI AC stimulator |
| Pseudo-Stimulator Group | Sham comparator | In this study, the group is the control group. Patients are randomly assigned to participate, and patients will be given simulated electrical stimulation. Receives: Device: Pseudo-stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of participants having an improvement at week 8
the proportion of participants having an improvement at week 8, which includes response per the Hamilton Depression Rating Scale 17-Item (HAMD-17) defined as a ≥ 50% reduction from the baseline or clinical recovery (score ≤ 7).
Measured: week 8
Secondary outcomes (13)
The proportions of participants achieve an improvement in neurological function
The improvement will be decided by a reduction of ≥ 50% or the total score of 0-1 in the National Institute of Health Stroke Scale (NIHSS) score (ranging from 0 to 42, higher scores indicate a more severe neurological deficit)
Measured: weeks 4 and 8
The proportions of participants achieve an improvement in independence
measured by a modified Rankin Scale (mRS) over the trial (scores on this scale range from 0 to 6, with higher scores indicating more significant disability), and the improvement is defined as 0, 1, and 2 in mRS.
Measured: weeks 4 and 8
The proportions of participants with a Barthel Index (BI) score of ≥ 90
the Barthel Index (BI) score is used to assess the activities of daily living (ranging from 0 to 100, higher scores indicate increased independence)
Measured: weeks 4 and 8
The proportions of participants having severity levels
the Clinical Global Impression-Severity (CGI-S) is a 7-point scale ranging from 1 being "normal, not at all ill" to 7 being "among the most extremely ill patients"
Measured: weeks 4 and 8
CGI-Improvement (CGI-I)
The proportions of participants have improvements of 1, 2, and 3 in the CGI-Improvement.
Measured: weeks 4 and 8
the Hamilton Anxiety Rating Scale (HAMA)
The changes of participants on anxiety symptoms
Measured: weeks 4 and 8
the Mini-Mental State Examination (MMSE)
The changes of participants on cognitive function assessed by MMSE
Measured: weeks 4 and 8
the Montreal Cognitive Assessment (MoCA)
The changes of participants on cognitive function
Measured: weeks 4 and 8
the proportion of participants having an improvement at week 4
the proportion of participants having an improvement at week 4, which includes response per the Hamilton Depression Rating Scale 17-Item (HAMD-17) defined as a ≥ 50% reduction from the baseline or clinical recovery (score ≤ 7).
Measured: week 4
the changes of beta-and gamma-oscillations at weeks 4 and 8
assessing the resting-state high-density EEG (rsHEEG) by utilizing a 128 channel EEG system (Geodesic EEG system 400, Electrical Geodesics, Inc., OR, USA) at baseline, week 4, and week 8.
Measured: weeks 4 and 8
the variations of cognitive status at weeks 4 and 8
to measure cognitive status of PSD by the repeatable battery for the assessment of neuropsychological status (RBANS) at baseline, week 4, and week 8.
Measured: weeks 4 and 8
the proportions of participants have an epileptic seizure at weeks 4 and 8
Electroencephalogram (EEG) of all patients will be recorded at baseline, week 4, and week 8. and the epileptic seizure will be verified by two independent experienced neurologists based on EEG activity and clinical manifestations.
Measured: weeks 4 and 8
the proportions of participants who have symptoms in the treatment-emergent symptom scale (TESS) at weeks 4 and 8
TESS will be assessed at weeks 4 and 8
Measured: weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start15 Aug 2019 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Model description
- Experiment Group: (NEXALIN ADI AC stimulators) vs Mock Group(pseudo-stimulators). Both require the same appearance, all kinds of buttons, buttons, lights, switches, settings, etc. are the same, but the pseudo-stimulator can not release current.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allen Song，MD & PHD, Xuanwu Hospital, Beijing
- Investigators
- Haiqing Song, doctor, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903068
- Sponsor's protocol ID
- 10000001
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shen X, Liu M, Cheng Y, Jia C, Pan X, Gou Q, Liu X, Cao H, Zhang L. Repetitive transcranial magnetic stimulation for the treatment of post-stroke depression: A systematic review and meta-analysis of randomized controlled clinical trials. J Affect Disord. 2017 Mar 15;211:65-74. doi: 10.1016/j.jad.2016.12.058. Epub 2017 Jan 10.
PubMed 28092847Gabis L, Shklar B, Baruch YK, Raz R, Gabis E, Geva D. Pain reduction using transcranial electrostimulation: a double blind "active placebo" controlled trial. J Rehabil Med. 2009 Mar;41(4):256-61. doi: 10.2340/16501977-0315.
PubMed 19247545Wang H, Zhang W, Zhao W, Wang K, Wang Z, Wang L, Peng M, Xue Q, Leng H, Ding W, Liu Y, Li N, Dong K, Zhang Q, Huang X, Xie Y, Chu C, Xue S, Huang L, Yao H, Ding J, Zhan S, Min B, Fan C, Zhou A, Sun Z, Yin L, Ma Q, Baskys A, Jorge RE, Song H. The efficacy of transcranial alternating current stimulation for treating post-stroke depression: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Apr;99(16):e19671. doi: 10.1097/MD.0000000000019671.
PubMed 32311940
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transcranial Alternating Current Stimulation for Treating Post-stroke Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03903068
- Acronym / sponsor ID
- 10000001
- Conditions
- Post-stroke Depression
- Keywords
- transcranial alternating current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Aug 2019 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 4 Apr 2019 (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.
Post-stroke depression (PSD) is one of the most common complications after stroke, with a high prevalence. PSD can affect prognosis and rehabilitation of stroke, increase risks of mortality and suicide, and escalate the economic burden on individuals and society. Studies have shown that transcranial alternating current stimulation (tACS) can also be used to treat depression, insomnia and anxiety. So far, this stimulator has been approved by FDA. However, there have not been any reports on the use of tACS in the treatment of depression and PSD in China. In this trial, the efficacy and safety of the tACS will be assessed with the rigor methodology manner.
Detailed description
Patients with post-stroke depression (PSD) have more dysfunction, poorer recovery outcomes, and higher morbidity and mortality in the first year after stroke onset than those patients without stroke. Some therapeutic methods have shown to be effective for PSD, including antidepressants, non-drug interventions, and combination therapies. However, pharmacological agents not only show unwanted side effects, including nausea, diarrhea, fatigue, and dizziness, but also produce high risk of hemorrhagic complications and stroke. Therefore, in addition to antidepressants treating PSD, non-drug interventions have been proposed to treat PSD. Until now, there are various physical techniques, including transcranial magnetic stimulation, vagus nerve stimulation, transcranial direct current stimulation, transcranial ultrasonic stimulation, etc. Previous studies have shown that transcranial alternating current stimulation (tACS) is commonly used to relieve pain, and has also been used to treat conditions such as transient tic disorder and cluster headaches. In the brain, there are specific opioid receptors which are not independent, and they work together with the electro analgesic system. Patients treated for chronic pain had lower levels of endorphins in their cerebrospinal fluid. Theoretically, using tACS can alleviate pain was caused by electrical stimulation to activate the brain's pain system (anti-nociceptive system), led to the beta-endorphin, serotonin and norepinephrine release.
Therefore, the study is expected to verify the effect of Transcranial Alternating Current Stimulation on patients with PSD in China and preliminarily explore the variations of gamma and beta-oscillations and cognitive function for the intervention of PSD utilized by it.
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
- Experiment Group: (NEXALIN ADI AC stimulators) vs Mock Group(pseudo-stimulators). Both require the same appearance, all kinds of buttons, buttons, lights, switches, settings, etc. are the same, but the pseudo-stimulator can not release current.
| Arm | Type | Receives |
|---|---|---|
| NEXALIN Stimulator Group | Experimental | Device: NEXALIN ADI AC stimulatorIn this study, the group is the treatment group. Patients are randomly assigned to participate, and patients will be given current parameters for setting time and flow. |
| Pseudo-Stimulator Group | Sham comparator | Device: Pseudo-stimulatorIn this study, the group is the control group. Patients are randomly assigned to participate, and patients will be given simulated electrical stimulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A diagnosis of PSD is based on the "Depressive disorder due to another medical condition" of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
- Age 18-70 years old, gender is not limited;
- Right-handed;
- More than 6 months after the onset of stroke;
- The duration of depressive disorder persists for more than two weeks;
Key exclusion criteria (10 listed)
- Patients with life expectancy < 6 months;
- Severe or unstable organic diseases;
- Acute brain injury and infection;
- The impaired skin integrity at the electrode placement site or skin allergic to electrode gel or adhesive;
- Active current suicidal intent or plan as shown by a score of ≥ 3 on the suicide item of HAMD-17;
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 |
|---|---|---|
| NEXALIN ADI AC stimulatorWhen the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. The three electrodes are placed in this way to enhance the performance of the Nexalin ADI device. When the device is activated, there will be a weak current passing through the forehead electrode and each mastoid electrode. The current intensity of Nexalin ADI treatment defaults to 15.00 mA and the duration defaults to 40 minutes. Both are preset to default parameters and cannot be changed. | Device | NEXALIN Stimulator Group |
| Pseudo-stimulatorWhen the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. When the device is started, no current flows through the electrodes, but the instrument's operating procedures, parameter displays, and prompts are the same as for a real instrument. | Device | Pseudo-Stimulator Group |
Primary outcome
the proportion of participants having an improvement at week 8
Time frame: week 8
the proportion of participants having an improvement at week 8, which includes response per the Hamilton Depression Rating Scale 17-Item (HAMD-17) defined as a ≥ 50% reduction from the baseline or clinical recovery (score ≤ 7).
13 secondary outcomes
The proportions of participants achieve an improvement in neurological function
Time frame: weeks 4 and 8
The proportions of participants achieve an improvement in independence
Time frame: weeks 4 and 8
The proportions of participants with a Barthel Index (BI) score of ≥ 90
Time frame: weeks 4 and 8
The proportions of participants having severity levels
Time frame: weeks 4 and 8
CGI-Improvement (CGI-I)
Time frame: weeks 4 and 8
the Hamilton Anxiety Rating Scale (HAMA)
Time frame: weeks 4 and 8
the Mini-Mental State Examination (MMSE)
Time frame: weeks 4 and 8
the Montreal Cognitive Assessment (MoCA)
Time frame: weeks 4 and 8
the proportion of participants having an improvement at week 4
Time frame: week 4
the changes of beta-and gamma-oscillations at weeks 4 and 8
Time frame: weeks 4 and 8
the variations of cognitive status at weeks 4 and 8
Time frame: weeks 4 and 8
the proportions of participants have an epileptic seizure at weeks 4 and 8
Time frame: weeks 4 and 8
the proportions of participants who have symptoms in the treatment-emergent symptom scale (TESS) at weeks 4 and 8
Time frame: weeks 4 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 28092847Shen X, Liu M, Cheng Y, Jia C, Pan X, Gou Q, Liu X, Cao H, Zhang L. Repetitive transcranial magnetic stimulation for the treatment of post-stroke depression: A systematic review and meta-analysis of randomized controlled clinical trials. J Affect Disord. 2017 Mar 15;211:65-74. doi: 10.1016/j.jad.2016.12.058. Epub 2017 Jan 10.
- Background: PubMed 19247545Gabis L, Shklar B, Baruch YK, Raz R, Gabis E, Geva D. Pain reduction using transcranial electrostimulation: a double blind "active placebo" controlled trial. J Rehabil Med. 2009 Mar;41(4):256-61. doi: 10.2340/16501977-0315.
- Derived from this study: PubMed 32311940Wang H, Zhang W, Zhao W, Wang K, Wang Z, Wang L, Peng M, Xue Q, Leng H, Ding W, Liu Y, Li N, Dong K, Zhang Q, Huang X, Xie Y, Chu C, Xue S, Huang L, Yao H, Ding J, Zhan S, Min B, Fan C, Zhou A, Sun Z, Yin L, Ma Q, Baskys A, Jorge RE, Song H. The efficacy of transcranial alternating current stimulation for treating post-stroke depression: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Apr;99(16):e19671. doi: 10.1097/MD.0000000000019671.
- The Official website of NEXALIN ADI AC stimulatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Haiqing Song, doctor principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEXALIN ADI AC stimulator and Pseudo-stimulator in people with Post-stroke Depression, run by Xuanwu Hospital, Beijing 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 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiqing Song, doctor (86-13701390976, songhq@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of participants having an improvement at week 8 (time frame: week 8). 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 NCT03903068, which also lists 3 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 13 Aug 2019.