ApathyTDCS-PSANCT02915484
Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy
A study testing Transcranial Direct Current Stimulation in people with Apathy and Stroke, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stroke and radiographically proven ischemic or hemorrhagic stroke (MRI required for ischemic stroke, CT sufficient for hemorrhagic stroke)
- Stroke occurred at least one month prior to first stimulation session
- Ability to provide informed consent
- Availability of a family member / caregiver who knew the subject before the stroke and interacts with the subject on at least a weekly basis
- Score of 6 or higher in initial apathy testing using Apathy Inventory - Clinician score
- Speak English (required for quantifying apathy and performing the cognitive tests)
Who cannot join
- Other potential cause of apathy including some neurodegenerative diseases, some psychiatric diseases, and anti-dopamine medication
- Prior brain injury (e.g., Traumatic Brain Injury (TBI), stroke) without full motor and cognitive recovery based on patient, family or clinician report
- Active medical illness (e.g., infection, delirium, etc.) that might affect arousal and cognitive function
- Hypoarousal (inability to maintain eye opening without stimulation) from any cause (e.g., stroke, sleep deprivation)
- Any history of epilepsy
- Recent drug or alcohol abuse - within the past year
Show all 9Show fewer
- Pregnant or breastfeeding
- Moderate to severe aphasia preventing subject from communicating fully
- Any pacemakers, intracranial electrodes, implanted defibrillators, or any other electrical implants
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients.
Read the detailed description
Post-stroke apathy is a condition where people show reduced emotions and reduced activity after their stroke, beyond that expected from their degree of weakness. It can occur with, or without, depression, and is associated with more disability and slower recovery. It is thought to be due to dysfunction of the front of the brain (prefrontal cortex). Importantly, there are no proven medical treatments for post-stroke apathy.
Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation technique that has the potential for alleviating post-stroke apathy. TDCS involves sending a weak electrical current through the head, thereby exciting the brain underneath. This offers potential advantages over medications as tDCS directly targets the brain, while medications need to travel through the bloodstream to reach the brain. TDCS is not an FDA-approved treatment for any condition, but previous trials have shown it may benefit movement and language recovery after stroke, as well as improve thinking ability. Studies have shown tDCS to be very safe with no serious adverse events in over 10,000 subjects studied.
This pilot study will involve three visits to Stony Brook University Hospital. The first is a baseline session where subjects perform all outcome measures but no tDCS is performed other than for familiarization. The second and third sessions are the stimulation sessions where subjects undergo the intervention for 20 minutes to test tDCS effects on the outcome measures. The effects of tDCS for a single session are expected to only last for few hours. Subjects are to receive one type of stimulation in one session and another type in the other session. If this study finds a short term benefit of tDCS for post-stroke apathy it will support a full clinical trial where multiple sessions of tDCS will be given and may provide a long-term benefit.
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Transcranial Direct Current Stimulation, Apathy, Stroke, Empathy, Electric Stimulation Therapy, Depression, Anhedonia, Prefrontal Cortex, Electroencephalography, Cognition, Emotions, Neurological Rehabilitation, Brain Diseases, Cerebrovascular Disorders
- Medical subject headings
- Lethargy, Stroke, Depression, Anhedonia, Brain Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called Neuroelectrics Starstim
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
| Study group | Role | What they receive |
|---|---|---|
| tDCS stimulation A | Experimental | Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex. Receives: Device: Transcranial Direct Current Stimulation |
| tDCS stimulation B | Experimental | Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Apathy Inventory Scale - Clinician
Measured: at the beginning of each session and 1 day after each session.
Secondary outcomes (6)
Changes in Apathy Inventory Scale - Subject
Measured: before and after each stimulation within 2 hours.
Changes in Apathy Inventory Scale - Family/Caregiver
Measured: at the beginning of each session and 1 day after each session.
Actimeter
Measured: Actimeter is worn from the beginning of the study to end of study (20 to 30 days)
Changes in Language Analysis tests
Measured: before and after each stimulation within 2 hours.
Changes in Cognitive Tasks
Measured: before and after each stimulation within 2 hours.
Changes in EEG
Measured: before and after each stimulation within 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Difficulty with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ApathyStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation
- Responsible party
- Principal investigator, Andrew Goldfine, Stony Brook University
- Investigators
- Andrew M Goldfine, MD, Principal investigator, Stony Brook Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915484
- Sponsor's protocol ID
- 798869
- Acronym
- TDCS-PSA
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2016
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
PubMed 22037126Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
PubMed 17452283
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy
- ClinicalTrials.gov ID
- NCT02915484
- Acronym / sponsor ID
- TDCS-PSA / 798869
- Keywords
- Transcranial Direct Current Stimulation, Apathy, Stroke, Empathy, Electric Stimulation Therapy, Depression, Anhedonia, Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment.
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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 study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients.
Detailed description
Post-stroke apathy is a condition where people show reduced emotions and reduced activity after their stroke, beyond that expected from their degree of weakness. It can occur with, or without, depression, and is associated with more disability and slower recovery. It is thought to be due to dysfunction of the front of the brain (prefrontal cortex). Importantly, there are no proven medical treatments for post-stroke apathy.
Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation technique that has the potential for alleviating post-stroke apathy. TDCS involves sending a weak electrical current through the head, thereby exciting the brain underneath. This offers potential advantages over medications as tDCS directly targets the brain, while medications need to travel through the bloodstream to reach the brain. TDCS is not an FDA-approved treatment for any condition, but previous trials have shown it may benefit movement and language recovery after stroke, as well as improve thinking ability. Studies have shown tDCS to be very safe with no serious adverse events in over 10,000 subjects studied.
This pilot study will involve three visits to Stony Brook University Hospital. The first is a baseline session where subjects perform all outcome measures but no tDCS is performed other than for familiarization. The second and third sessions are the stimulation sessions where subjects undergo the intervention for 20 minutes to test tDCS effects on the outcome measures. The effects of tDCS for a single session are expected to only last for few hours. Subjects are to receive one type of stimulation in one session and another type in the other session. If this study finds a short term benefit of tDCS for post-stroke apathy it will support a full clinical trial where multiple sessions of tDCS will be given and may provide a long-term benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS stimulation A | Experimental | Device: Transcranial Direct Current StimulationIntervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex. |
| tDCS stimulation B | Experimental | Device: Transcranial Direct Current StimulationIntervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of stroke and radiographically proven ischemic or hemorrhagic stroke (MRI required for ischemic stroke, CT sufficient for hemorrhagic stroke)
- Stroke occurred at least one month prior to first stimulation session
- Ability to provide informed consent
- Availability of a family member / caregiver who knew the subject before the stroke and interacts with the subject on at least a weekly basis
- Score of 6 or higher in initial apathy testing using Apathy Inventory - Clinician score
Key exclusion criteria (9 listed)
- Other potential cause of apathy including some neurodegenerative diseases, some psychiatric diseases, and anti-dopamine medication
- Prior brain injury (e.g., Traumatic Brain Injury (TBI), stroke) without full motor and cognitive recovery based on patient, family or clinician report
- Active medical illness (e.g., infection, delirium, etc.) that might affect arousal and cognitive function
- Hypoarousal (inability to maintain eye opening without stimulation) from any cause (e.g., stroke, sleep deprivation)
- Any history of epilepsy
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 Direct Current StimulationAlso: Neuroelectrics StarstimTDCS involves sending a weak electrical current to the brain to modulate brain functions. | Device | tDCS stimulation A, tDCS stimulation B |
Primary outcome
Changes in Apathy Inventory Scale - Clinician
Time frame: at the beginning of each session and 1 day after each session.
6 secondary outcomes
Changes in Apathy Inventory Scale - Subject
Time frame: before and after each stimulation within 2 hours.
Changes in Apathy Inventory Scale - Family/Caregiver
Time frame: at the beginning of each session and 1 day after each session.
Actimeter
Time frame: Actimeter is worn from the beginning of the study to end of study (20 to 30 days)
Changes in Language Analysis tests
Time frame: before and after each stimulation within 2 hours.
Changes in Cognitive Tasks
Time frame: before and after each stimulation within 2 hours.
Changes in EEG
Time frame: before and after each stimulation within 2 hours.
Results and safety
The study was stopped early (reason given: Difficulty with recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Background: PubMed 22037126Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
- Background: PubMed 17452283Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
- 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.
Andrew M Goldfine, MD principal investigator
Stony Brook Medicine
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 Direct Current Stimulation in people with Apathy and Stroke, run by Stony Brook University 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 6 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: stopped early, as of the sponsor's last update on 3 Oct 2017. 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 was stopped early (reason given: Difficulty with recruitment.). Results are not available in the source record.
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?
Changes in Apathy Inventory Scale - Clinician (time frame: at the beginning of each session and 1 day after each session.). 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 NCT02915484, which also lists 2 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 3 Oct 2017.