Last updated: April 19, 2021
Sponsor: Johns Hopkins University
Overall Status: Terminated
Phase
N/A
Condition
Memory Loss
Pain (Pediatric)
Mild Cognitive Impairment
Treatment
N/AClinical Study ID
NCT03143894
IRB00110211
J16135
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women, 18 years of age or older
- Stage I-III breast cancer
- Treatment Status: At least 6 months and no more than 5 years after the conclusion ofactive breast cancer therapy, including surgery, radiation therapy and (neo)adjuvantchemotherapy, if administered. NOTE: Adjuvant HER2-targeted therapy and endocrinetherapy may still be ongoing at the time of study enrollment.
- Fatigue: Moderate fatigue on most days within the past week (i.e., at least 4 out ofthe last 7 days), rated as ≥ 4 on a 0 (no fatigue) to 10 (worst fatigue) scale.
- Able and willing to complete study tasks as evidenced by at least the following:fluent English speaker; hearing and language comprehension; and, sufficient literacyto complete study forms and questionnaires.
- Patient understands the study regimen, its requirements, risks, and discomforts, andis able and willing to sign an informed consent form.
Exclusion
Exclusion Criteria:
- Evidence of recurrent breast cancer at the time of enrollment.
- Depression or anxiety as defined either by ongoing pharmacological treatment fordepression or anxiety or a HADS score on initial screening.
- Dementia as assessed by a MMSE score on initial screening.
- Known pregnancy or nursing.
- Any of the following: diagnosis of schizophrenia or bipolar disorder made by aphysician, seizure disorder, pacemaker, hearing aids, any metal implanted in the head,or the presence of other known current untreated causes of fatigue such as anemia oruntreated hypothyroidism.
- Use of stimulant medications, sleep medications, nicotine patch, and other drugsthought to interfere with tDCS efficacy for seven days prior to and during studyparticipation.
- Use of narcotic pain medication, benzodiazepines, or illicit drugs for seven daysprior to and during study participation.
- Consumption of >14 alcoholic drinks per week or positive screening on the CAGE.
- Skin conditions involving open sores on the scalp that would prevent properapplication of the electrodes.
- Hairstyles that obstruct placement of the electrodes including cornrows, dreadlocks,braids or other hair accessories that cannot be removed.
- Other medical or other condition(s) that in the opinion of the investigators mightcompromise the objectives of the study.
Study Design
Total Participants: 7
Study Start date:
April 21, 2017
Estimated Completion Date:
June 24, 2020
Study Description
Connect with a study center
Sibley Memorial Hospital
Washington, District of Columbia 20016
United StatesSite Not Available
Sibley Memorial Hospital
Washington, D.C., District of Columbia 20016
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Greenspring Station
Lutherville, Maryland 21093
United StatesSite Not Available

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