This preprint is under consideration at BMC Neurology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Percutaneous Mastoid Electrical Stimulator Improves Poststroke Depression and Cognitive F unction in Patients with Ischaemic Stroke: A Prospective, Randomized, Double-blind, and Sham-controlled Study
Lanying He
Second people's Hospital of Chengdu
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7127-6333
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background : Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function.
Methods: This study was a prospective, randomized, double-blind, and sham-controlled study . A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N=125) and sham plus antidepressant (sham group, N=133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score≤9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score <26 .
Results: The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P=0.009; 44.00% vs 29.32%, P=0.014 respectively). The mean value of the HRSD score change [M(month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (-11.93 ±5.32 vs -10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores <26 was lower in the PEMS group than in the sham group(12.0% vs 24.06%, P=0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50±2.55 vs 2.72±2.52, P=0.005,respectively).
Conclusion: These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. Trial registration: This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018
Keywords
acute ischaemic stroke, percutaneous mastoid electrical stimulator, poststroke depression, cognition
Figure 1
Figure 2
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 4
Posted 14 Apr, 2020
No community comments so far
Submission checks complete
On 08 Apr, 2020
No comments provided
Editorial decision: Minor revision
On 01 Apr, 2020
Editor assigned
On 25 Mar, 2020
Submission checks complete
On 24 Mar, 2020
Editor invited
On 24 Mar, 2020
No comments provided
Review #2 received
Received 18 Mar, 2020
Editorial decision: Minor revision
On 18 Mar, 2020
Review #1 received
Received 12 Mar, 2020
Reviewer #2 agreed
On 04 Mar, 2020
Reviewers invited
Invitations sent on 01 Mar, 2020
Reviewer #1 agreed
On 01 Mar, 2020
Editor assigned
On 21 Feb, 2020
Submission checks complete
On 20 Feb, 2020
Editor invited
On 20 Feb, 2020
No comments provided
Review #2 received
Received 11 Feb, 2020
Editorial decision: Major revision
On 11 Feb, 2020
Reviewer #2 agreed
On 29 Jan, 2020
Review #1 received
Received 14 Dec, 2019
Reviewers invited
Invitations sent on 21 Nov, 2019
Reviewer #1 agreed
On 21 Nov, 2019
Editor assigned
On 15 Nov, 2019
Submission checks complete
On 14 Nov, 2019
Editor invited
On 14 Nov, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Neurology
Learn more about our company.
This preprint is under consideration at BMC Neurology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Percutaneous Mastoid Electrical Stimulator Improves Poststroke Depression and Cognitive F unction in Patients with Ischaemic Stroke: A Prospective, Randomized, Double-blind, and Sham-controlled Study
Lanying He
Second people's Hospital of Chengdu
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7127-6333
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 4
Posted 14 Apr, 2020
No community comments so far
Submission checks complete
On 08 Apr, 2020
No comments provided
Editorial decision: Minor revision
On 01 Apr, 2020
Editor assigned
On 25 Mar, 2020
Submission checks complete
On 24 Mar, 2020
Editor invited
On 24 Mar, 2020
No comments provided
Review #2 received
Received 18 Mar, 2020
Editorial decision: Minor revision
On 18 Mar, 2020
Review #1 received
Received 12 Mar, 2020
Reviewer #2 agreed
On 04 Mar, 2020
Reviewers invited
Invitations sent on 01 Mar, 2020
Reviewer #1 agreed
On 01 Mar, 2020
Editor assigned
On 21 Feb, 2020
Submission checks complete
On 20 Feb, 2020
Editor invited
On 20 Feb, 2020
No comments provided
Review #2 received
Received 11 Feb, 2020
Editorial decision: Major revision
On 11 Feb, 2020
Reviewer #2 agreed
On 29 Jan, 2020
Review #1 received
Received 14 Dec, 2019
Reviewers invited
Invitations sent on 21 Nov, 2019
Reviewer #1 agreed
On 21 Nov, 2019
Editor assigned
On 15 Nov, 2019
Submission checks complete
On 14 Nov, 2019
Editor invited
On 14 Nov, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Neurology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background : Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function.
Methods: This study was a prospective, randomized, double-blind, and sham-controlled study . A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N=125) and sham plus antidepressant (sham group, N=133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score≤9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score <26 .
Results: The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P=0.009; 44.00% vs 29.32%, P=0.014 respectively). The mean value of the HRSD score change [M(month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (-11.93 ±5.32 vs -10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores <26 was lower in the PEMS group than in the sham group(12.0% vs 24.06%, P=0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50±2.55 vs 2.72±2.52, P=0.005,respectively).
Conclusion: These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. Trial registration: This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018
Figure 1
Figure 2