Post-stroke DepressionPSDNCT05612659
Developing an EEG Probe for Studying and Modulating Cognitive Control
A study testing Transcranial Electrical stimulation and Transcutaneous direct current stimulation in people with Post-stroke Depression, run by University of Cincinnati at 1 site in United States.
Trial summary
This study aims to investigate effects of transcranial current stimulation (tES) and transcutaneous direct current stimulation (tsDCS) associated changes on fronto-parietal EEG and cognitive performance in patients with post stroke depression (PSD) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Transcranial Electrical stimulation and Transcutaneous direct current stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 30 May 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke.
- Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke
Who cannot join
- Current or lifetime bipolar disorder or schizophrenia diagnosis;
- current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed);
- significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year:
- current chronic severe pain conditions;
- current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month);
- skin lesions on electrode placement region;
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- implanted electrical medical devices;
- Pregnancy;
- suspected IQ<80, and 10) any other clinically relevant reason as judged by the clinician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing an EEG Probe for Studying Effects of Non-invasive Cortical and Spinal Cord Electrical Stimulation on Cognitive Control in Post Stroke Depression
This study aims to investigate effects of transcranial current stimulation (tES) and transcutaneous direct current stimulation (tsDCS) associated changes on fronto-parietal EEG and cognitive performance in patients with post stroke depression (PSD)
Read the detailed description
The investigators will perform a double blind, randomized, sham controlled, crossover study design to assess effects of tES, tsDCS and sham stimulation on the performance during a cognitive control task. The working Hypothesis is tsDCS and/or tES will enhance frontal theta oscillations as recorded on EEGs and improve task performance compared to sham stimulation.
Results from this project can potentially lead to the development of a new research tool for assessing neuromodulation strategies to treat mental disorders and their comorbidities. It will also uncover the neural correlates of cognitive deficits in PSD and provide feasible biomarkers associated with treatment response in support of a larger clinical.
- Conditions
- Post-stroke Depression
- Being tested
- Transcranial Electrical stimulation, Transcutaneous direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Electrical stimulationProcedure or surgery
Noninvasive electrical stimulation of lateral frontal cortex.
Transcutaneous direct current stimulationProcedure or surgery
Noninvasive electrical stimulation of the T10 spinal column.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Electrical stimulation | Experimental | Subjects will receive transcranial electrical stimulation. Receives: Procedure: Transcranial Electrical stimulation |
| Transcutaneous direct current stimulation | Experimental | Subjects will receive Transcutaneous direct current stimulation Receives: Procedure: Transcutaneous direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG oscillations
Theta (4-8 Hz) oscillations in the mid frontal EEG
Measured: change from baseline
Secondary outcomes (1)
Behavior
Response time in a multi source interference task
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start28 Sep 2022
- Primary completion31 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishita Basu, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612659
- Sponsor's protocol ID
- EEG_noninvasive_stimulation
- Acronym
- PSD
- Status last verified
- Jun 2024
- First submitted
- 31 Oct 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an EEG Probe for Studying Effects of Non-invasive Cortical and Spinal Cord Electrical Stimulation on Cognitive Control in Post Stroke Depression
- ClinicalTrials.gov ID
- NCT05612659
- Acronym / sponsor ID
- PSD / EEG_noninvasive_stimulation
- Conditions
- Post-stroke Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 10 Nov 2022 (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.
This study aims to investigate effects of transcranial current stimulation (tES) and transcutaneous direct current stimulation (tsDCS) associated changes on fronto-parietal EEG and cognitive performance in patients with post stroke depression (PSD)
Detailed description
The investigators will perform a double blind, randomized, sham controlled, crossover study design to assess effects of tES, tsDCS and sham stimulation on the performance during a cognitive control task. The working Hypothesis is tsDCS and/or tES will enhance frontal theta oscillations as recorded on EEGs and improve task performance compared to sham stimulation.
Results from this project can potentially lead to the development of a new research tool for assessing neuromodulation strategies to treat mental disorders and their comorbidities. It will also uncover the neural correlates of cognitive deficits in PSD and provide feasible biomarkers associated with treatment response in support of a larger clinical.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Electrical stimulation | Experimental | Procedure: Transcranial Electrical stimulationSubjects will receive transcranial electrical stimulation. |
| Transcutaneous direct current stimulation | Experimental | Procedure: Transcutaneous direct current stimulationSubjects will receive Transcutaneous direct current stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke.
- Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke
Key exclusion criteria (9 listed)
- Current or lifetime bipolar disorder or schizophrenia diagnosis;
- current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed);
- significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year:
- current chronic severe pain conditions;
- current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month);
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 Electrical stimulationNoninvasive electrical stimulation of lateral frontal cortex. | Procedure or surgery | Transcranial Electrical stimulation |
| Transcutaneous direct current stimulationNoninvasive electrical stimulation of the T10 spinal column. | Procedure or surgery | Transcutaneous direct current stimulation |
Primary outcome
EEG oscillations
Time frame: change from baseline
Theta (4-8 Hz) oscillations in the mid frontal EEG
1 secondary outcome
Behavior
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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 Transcranial Electrical stimulation and Transcutaneous direct current stimulation in people with Post-stroke Depression, run by University of Cincinnati at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 27 Jun 2024. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EEG oscillations (time frame: change from baseline). 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 27 Jun 2024; AzTrials last refreshed its copy on 28 Oct 2026.