Transcranial Direct Current Stimulation (tDCS) to Improve Fatigue and Cognitive Function
Completed · Not applicable · Has a placebo group
Conditions studied: Breast Cancer, Fatigue
In brief
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.
Key facts
- Study ID
- NCT03487601
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 3
- Starts
- 2017-12-12
- Expected to finish
- 2019-02-16
- Last updated by the study team
- 2021-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- 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
Where it is running
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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