Breast CancerNCT03487601
Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function
A study testing transcranial direct current stimulation in people with Breast Cancer and Fatigue, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve fatigue and certain thinking skills in women with breast cancer receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Fatigue
- What is being tested?
- transcranial direct current stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2017to 16 Feb 2019
- 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
- Women or men, 18 years of age or older
- Stage I-IV breast cancer receiving docetaxel-based chemotherapy (at least 60 mg/m2) every 21 days
- Docetaxel may be administered concurrently with other chemotherapy agents and/or with HER2 targeted therapies at the discretion of the treating provider
- Fatigue: Self-report of moderate or severe fatigue on at least 3 days during the prior cycle of docetaxel-based chemotherapy, defined as ≥ 4 on a 0 (no fatigue) to 10 (worst fatigue imaginable) scale.
- Able and willing to complete study tasks as evidenced by at least the following according to the assessment of a study team member: fluent English speaker; hearing and language comprehension; and, sufficient literacy to complete study forms and questionnaires
- Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Who cannot join
- Dementia as assessed by a MMSE score < 24 on initial screening.
- Known pregnancy or nursing.
- Any of the following: known diagnosis of schizophrenia or bipolar disorder, seizure disorder, pacemaker, hearing aids, any metal implanted in the head, untreated hypothyroidism, aphasia, delirium, known neurologic disorder which affects cognitive function, prior traumatic brain injury, known heart failure
- Note: presence of a mediport is not an exclusion criteria
- Use of the following medications for seven days prior to and during study participation:
- Stimulant medications
Show all 23Show fewer
- Carbamazepine/Tegretol
- Cough/cold medicines (e.g. Dextromethorphan, Triaminic, Robitussin, Vics Formula 44)
- Flunarizine/Sibelium
- Propanolol/Inderal
- Sulpiride
- Pergolide
- Rivastigmine/Exelon
- Carbidopa/levodopa or levodopa
- Ropinirole/Requip
- Nicotine patch
- Use of illicit drugs for seven days prior to and during study participation.
- Self-reported consumption of > 14 alcoholic drinks per week or positive screening on the CAGE questionnaire in relation to the past year. NOTE: A single, standard alcoholic drink is defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine or 30 mL of liquor.
- Skin conditions involving open sores on the scalp that would prevent proper application of the electrodes.
- Hairstyles that obstruct placement of the electrodes including cornrows, dreadlocks, braids or other hair accessories that cannot be removed.
- Known history of brain metastases or leptomeningeal carcinomatosis (even if adequately treated)
- Prior brain surgery
- Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function During Breast Cancer Chemotherapy: A Feasibility Study
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve fatigue and certain thinking skills in women with breast cancer receiving chemotherapy.
Transcranial Direct Current Stimulation is a form of brain stimulation during which low amounts of electrical current are delivered to the brain using electrodes attached to the scalp. The idea of using electrical stimulation to affect neurological symptoms has been around for more than 100 years with the first reported use in 1801. Since the 1960s, tDCS has been used in research for a variety of reasons including stroke rehabilitation, memory enhancement and for depression.
People aged 18 or older who are currently receiving chemotherapy with docetaxel and who are experiencing fatigue may join.
Read the detailed description
Fatigue and cognitive impairment are commonly reported symptoms associated with impaired quality of life (QOL) and productivity in breast cancer patients receiving chemotherapy. Working memory, the brain's system for temporarily storing and manipulating information required to carry out more complex cognitive tasks, is particularly affected by cancer and its treatment.
In women who have undergone chemotherapy for breast cancer, neuroimaging studies show structural brain changes as well as functional inefficiencies in a region critical for working memory, the left dorsolateral prefrontal cortex (DLPFC). Fatigue appears to play a critical role in the recruitment of the DLPFC during cognitive tasks.
Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form of electrical brain stimulation that enhances neuronal transmission beneath scalp electrodes. Our group and others have shown that when applied to the left DLPFC, tDCS improves energy in patients with fatiguing medical conditions and that it improves cognition in both healthy adults and those with neurodegenerative diseases.
The proposed feasibility trial is a randomized, sham-controlled, double-blind experiment. Eligible individuals will be ≥ age 18 years with stage I-IV breast cancer undergoing docetaxel-based chemotherapy every 3 weeks (at least 60 mg/m2 dose) with or without HER2-targeted therapy who self-report moderate or severe fatigue (rated ≥ 4 on a scale of 0-10) during at least 3 days of their most recent chemotherapy cycle. Participants will be randomized to either active or sham tDCS and will undergo 5 consecutive treatments of daily tDCS beginning the Monday following the first day of their on-study chemotherapy cycle. Active treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days. Sham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants.
Participants will complete self-report measures of fatigue, cognitive function and QOL along with cognitive testing at the beginning and end of the five-day intervention. Subjective fatigue, QOL and cognitive function will be also assessed prior to administration of the next cycle of chemotherapy. Total time on study will be approximately 3 weeks (one cycle of chemotherapy). Daily subjective fatigue will be monitored throughout participation.
- Conditions
- Breast Cancer, Fatigue
- Being tested
- transcranial direct current stimulation, sham transcranial direct current stimulation
- Keywords
- docetaxel, Stage I - IV, chemotherapy
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationOther
Also called tDCS
Active treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days.
sham transcranial direct current stimulationOther
Also called sham stimulation
Sham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Active transcranial direct current stimulation: Participants will undergo five consecutive days (Monday-Friday) of active stimulation beginning the Monday after their on-study chemotherapy administration. Questionnaires and cognitive assessment will be completed on the first and last days of stimulation (i.e., Monday and Friday). On all 5 days, participants will engage in cognitive tasks while receiving stimulation (either active or sham) in order to maximize stimulation effects 43. In order to assess for duration of subjective effects, participants will complete self-report measures of subjective fatigue, cognitive function and QOL immediately prior to their next chemotherapy (approximately 10-14 days after completion of stimulation). Receives: Other: transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Sham transcranial direct current stimulation: Participants will undergo five consecutive days (Monday-Friday) of sham stimulation beginning the Monday after their on-study chemotherapy administration. Questionnaires and cognitive assessment will be completed on the first and last days of stimulation (i.e., Monday and Friday). On all 5 days, participants will engage in cognitive tasks while receiving stimulation (either active or sham) in order to maximize stimulation effects 43. In order to assess for duration of subjective effects, participants will complete self-report measures of subjective fatigue, cognitive function and QOL immediately prior to their next chemotherapy (approximately 10-14 days after completion of stimulation). Receives: Other: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of tDCS
Evaluation of the feasibility of 5 consecutive days of tDCS in breast cancer patients receiving docetaxel-based chemotherapy. Feasibility will be evaluated by assessing the proportion of study participants who complete at least 4 of 5 days of the planned tDCS intervention (active or sham) during docetaxel-based chemotherapy. If >80% of participants complete 4 of the 5 planned stimulation sessions, tDCS will be defined as feasible.
Measured: Day 5
Secondary outcomes (4)
Fatigue
Participants will complete self-report measures of fatigue. The Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) will serve as the primary measurement tool for the assessment of subjective fatigue. This questionnaire assesses participants' subjective ratings across five subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. Responses are provided on 5-point Likert-like scales addressing the extent to which each symptom was experienced during the preceding 7 days ranging from 0 (not at all) to 4 (extremely). The subscale scores are obtained by summing scores within each subscale. The MFSI-SF total score is obtained by subtracting the vigor subscale score from the sum of the four fatigue subscales. Scores range from -36 to 144. The MFSI-SF is well validated in breast cancer patients. Breast cancer patients with fatigue produce an average score of 14.7 ± 15.2. The MFSI-SF takes approximately 5 minutes to complete.
Measured: Day 1, Day 5, and at End of study (approximately 3 weeks)
Subjective Cognitive Function
Participants will self-report measures of cognitive function at the beginning and end of the five-day intervention. The endpoint for subjective cognition will be scores on the FACT-Cog, a 37-item self-report measure. Responses are provided on 5-point Likert-like scales addressing the frequency with which each type of cognitive difficulty occurred from 0 (never) to 4 (several times a day) over the prior seven days. Two additional subscales address "noticeability" or comments from others regarding cognition and "effect of perceived cognitive impairment on quality of life." These are rated on 5-point Likert-like scales ranging from 0 (not at all) to 4 (very much). The total FACT-Cog score is obtained by summing the individual subscale scores and ranges from 0 to 148. Breast cancer patients produce a mean FACT-Cog total score of 119.0 ± 23.3.The FACT-Cog takes approximately 5 minutes to complete.
Measured: Day 1, Day 5, and at end of study (approximately 3 weeks)
Objective Cognitive Function
Objective cognitive function from baseline (prior to tDCS) to completion of tDCS will be assessed. The measurement tool for objective cognitive function for this objective will be the Paced Auditory Serial Addition Test (PASAT) of working memory. The PASAT is working memory task that has been well-validated medical populations including breast cancer. Test administration involves the aural presentation of single digits via computer in order to ensure a standardized rate of stimulus presentation. Stimuli are presented every three seconds (trial 1) or every two seconds (trial 2). Participants add each new digit to the one immediately prior as the test continues to present stimuli. The test score reflects the total number of correct sums given (out of 60 possible) in each trial. Two equivalent, alternative PASAT forms will be used to minimize practice effects. The test takes approximately 10 minutes to complete.
Measured: Day 1 and Day 5
Quality of Life
The measurement tool for QOL will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The impact of tDCS on QOL will be assessed by the EORTC QLQ-C30. This 30-item questionnaire includes five functional scales (physical, role, emotional, social and cognitive), three symptom scales (fatigue, nausea/vomiting and pain), a global health status scale and six single items (dyspnea, constipation, diarrhea, appetite, sleep and financial difficulty). The first 28 questions are answered using a Likert-like scale ranging from 1, "not at all", to 4, "very much". The last two questions are answered on a Likert-like scale ranging from 1, "poor" to 7, "excellent". The recall period is 7 days. The EORTC QLQ-C30 has been extensively used as a quality of life measure in breast cancer clinical trials and is well validated in the breast cancer population. The EORTC QLQ-C30 takes approximately 5 minutes to complete.
Measured: Day 1, Day 5, End of study (approximately 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start12 Dec 2017
- Primary completion16 Feb 2019
- Study completion16 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed feasibility trial is a randomized, sham-controlled, double-blind experiment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Karen Smith, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487601
- Sponsor's protocol ID
- J17138
- Other IDs
- IRB00140819
- Status last verified
- Jul 2020
- First submitted
- 2 Feb 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the feasibility endpoint, we will report the count, proportion, and 90% confidence interval of participants completing at least 4 tDCS sessions. The summary statistics will be reported by study arm and for all patients.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function During Breast Cancer Chemotherapy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03487601
- Acronym / sponsor ID
- J17138
- Conditions
- Breast Cancer, Fatigue
- Keywords
- docetaxel, Stage I - IV, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 4 Apr 2018 (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 research is being done to determine whether transcranial direct current stimulation (tDCS) can improve fatigue and certain thinking skills in women with breast cancer receiving chemotherapy.
Transcranial Direct Current Stimulation is a form of brain stimulation during which low amounts of electrical current are delivered to the brain using electrodes attached to the scalp. The idea of using electrical stimulation to affect neurological symptoms has been around for more than 100 years with the first reported use in 1801. Since the 1960s, tDCS has been used in research for a variety of reasons including stroke rehabilitation, memory enhancement and for depression.
People aged 18 or older who are currently receiving chemotherapy with docetaxel and who are experiencing fatigue may join.
Detailed description
Fatigue and cognitive impairment are commonly reported symptoms associated with impaired quality of life (QOL) and productivity in breast cancer patients receiving chemotherapy. Working memory, the brain's system for temporarily storing and manipulating information required to carry out more complex cognitive tasks, is particularly affected by cancer and its treatment.
In women who have undergone chemotherapy for breast cancer, neuroimaging studies show structural brain changes as well as functional inefficiencies in a region critical for working memory, the left dorsolateral prefrontal cortex (DLPFC). Fatigue appears to play a critical role in the recruitment of the DLPFC during cognitive tasks.
Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form of electrical brain stimulation that enhances neuronal transmission beneath scalp electrodes. Our group and others have shown that when applied to the left DLPFC, tDCS improves energy in patients with fatiguing medical conditions and that it improves cognition in both healthy adults and those with neurodegenerative diseases.
The proposed feasibility trial is a randomized, sham-controlled, double-blind experiment. Eligible individuals will be ≥ age 18 years with stage I-IV breast cancer undergoing docetaxel-based chemotherapy every 3 weeks (at least 60 mg/m2 dose) with or without HER2-targeted therapy who self-report moderate or severe fatigue (rated ≥ 4 on a scale of 0-10) during at least 3 days of their most recent chemotherapy cycle. Participants will be randomized to either active or sham tDCS and will undergo 5 consecutive treatments of daily tDCS beginning the Monday following the first day of their on-study chemotherapy cycle. Active treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days. Sham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants.
Participants will complete self-report measures of fatigue, cognitive function and QOL along with cognitive testing at the beginning and end of the five-day intervention. Subjective fatigue, QOL and cognitive function will be also assessed prior to administration of the next cycle of chemotherapy. Total time on study will be approximately 3 weeks (one cycle of chemotherapy). Daily subjective fatigue will be monitored throughout participation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The proposed feasibility trial is a randomized, sham-controlled, double-blind experiment.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Other: transcranial direct current stimulationActive transcranial direct current stimulation: Participants will undergo five consecutive days (Monday-Friday) of active stimulation beginning the Monday after their on-study chemotherapy administration. Questionnaires and cognitive assessment will be completed on the first and last days of stimulation (i.e., Monday and Friday). On all 5 days, participants will engage in cognitive tasks while receiving stimulation (either active or sham) in order to maximize stimulation effects 43. In order to assess for duration of subjective effects, participants will complete self-report measures of subjective fatigue, cognitive function and QOL immediately prior to their next chemotherapy (approximately 10-14 days after completion of stimulation). |
| Sham tDCS | Sham comparator | Other: sham transcranial direct current stimulationSham transcranial direct current stimulation: Participants will undergo five consecutive days (Monday-Friday) of sham stimulation beginning the Monday after their on-study chemotherapy administration. Questionnaires and cognitive assessment will be completed on the first and last days of stimulation (i.e., Monday and Friday). On all 5 days, participants will engage in cognitive tasks while receiving stimulation (either active or sham) in order to maximize stimulation effects 43. In order to assess for duration of subjective effects, participants will complete self-report measures of subjective fatigue, cognitive function and QOL immediately prior to their next chemotherapy (approximately 10-14 days after completion of stimulation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women or men, 18 years of age or older
- Stage I-IV breast cancer receiving docetaxel-based chemotherapy (at least 60 mg/m2) every 21 days
- Fatigue: Self-report of moderate or severe fatigue on at least 3 days during the prior cycle of docetaxel-based chemotherapy, defined as ≥ 4 on a 0 (no fatigue) to 10 (worst fatigue imaginable) scale.
- Able and willing to complete study tasks as evidenced by at least the following according to the assessment of a study team member: fluent English speaker; hearing and language comprehension; and, sufficient literacy to complete study forms and questionnaires
- Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Key exclusion criteria (23 listed)
- Dementia as assessed by a MMSE score < 24 on initial screening.
- Known pregnancy or nursing.
- Any of the following: known diagnosis of schizophrenia or bipolar disorder, seizure disorder, pacemaker, hearing aids, any metal implanted in the head, untreated hypothyroidism, aphasia, delirium, known neurologic disorder which affects cognitive function, prior traumatic brain injury, known heart failure
- Use of the following medications for seven days prior to and during study participation:
- Use of illicit drugs for seven days prior to and during study participation.
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: tDCSActive treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days. | Other | Active tDCS |
| sham transcranial direct current stimulationAlso: sham stimulationSham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants. | Other | Sham tDCS |
Primary outcome
Feasibility of tDCS
Time frame: Day 5
Evaluation of the feasibility of 5 consecutive days of tDCS in breast cancer patients receiving docetaxel-based chemotherapy. Feasibility will be evaluated by assessing the proportion of study participants who complete at least 4 of 5 days of the planned tDCS intervention (active or sham) during docetaxel-based chemotherapy. If >80% of participants complete 4 of the 5 planned stimulation sessions, tDCS will be defined as feasible.
4 secondary outcomes
Fatigue
Time frame: Day 1, Day 5, and at End of study (approximately 3 weeks)
Subjective Cognitive Function
Time frame: Day 1, Day 5, and at end of study (approximately 3 weeks)
Objective Cognitive Function
Time frame: Day 1 and Day 5
Quality of Life
Time frame: Day 1, Day 5, End of study (approximately 3 weeks)
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 15 Jan 2021.
- Individual participant dataSharing planned: No. For the feasibility endpoint, we will report the count, proportion, and 90% confidence interval of participants completing at least 4 tDCS sessions. The summary statistics will be reported by study arm and for all patients.
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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.
Karen Smith, MD principal investigator
Johns Hopkins University
2 sites 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 Breast Cancer and Fatigue, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites 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 23 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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?
Feasibility of tDCS (time frame: Day 5). 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 15 Jan 2021.