Transcranial Alternating Current Stimulation Treating Post-stroke Depression

NCT03903068 | Unknown DMC FDA Device

• 1 other identifier: 10000001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post-stroke Depression

Keywords

transcranial alternating current stimulation

Outcome Measures

Primary Outcomes (1)

• 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).

  week 8

Secondary Outcomes (13)

• The proportions of participants achieve an improvement in neurological function

  weeks 4 and 8

• The proportions of participants achieve an improvement in independence

  weeks 4 and 8

• The proportions of participants with a Barthel Index (BI) score of ≥ 90

  weeks 4 and 8

• The proportions of participants having severity levels

  weeks 4 and 8

• CGI-Improvement (CGI-I)

  weeks 4 and 8

Study Arms (2)

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.

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.

Device: Pseudo-stimulator

Interventions

NEXALIN ADI AC stimulator DEVICE

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.

NEXALIN Stimulator Group

Pseudo-stimulator DEVICE

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.

Pseudo-Stimulator Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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,;
• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 28092847 BACKGROUND

• Gabis 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.

  PMID: 19247545 BACKGROUND

• Wang 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.

  PMID: 32311940 DERIVED

Related Links

• The Official website of NEXALIN ADI AC stimulator

Study Officials

• Haiqing Song, doctor

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiqing Song, doctor

CONTACT

86-13701390976; songhq@xwhosp.org

Zu Wang

CONTACT

86-13260189598; wangzu0606@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is blind to participant, care provider, investigator, outcomes assessor. If a serious adverse event occurs, stop treatment immediately.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chief of Neurology Department

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: August 15, 2019
• Primary Completion: August 15, 2020
• Study Completion: October 30, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)