Status:
NOT_YET_RECRUITING
tDCS for Cancer-Related Fatigue and Weakness
Lead Sponsor:
Kessler Foundation
Conditions:
Cancer-related Fatigue
Neuromodulation
Eligibility:
All Genders
40-80 years
Phase:
EARLY_PHASE1
Brief Summary
This pilot study investigates the effectiveness of non-invasive brain stimulation (tDCS) in alleviating cancer-related fatigue (CRF) and muscle weakness. Using a randomized, double-blind crossover des...
Eligibility Criteria
Inclusion
- General Inclusion - All participants
- Aged 40-80
- Right Handed, as determined by the Edinburgh Inventory 21
- Proficient in English
- Must be available for the familiarization, and testing sessions
- General Inclusion - Cancer Patients only
- Cancer (\>6 months post therapy)
- Suffers from a subjective feeling of cancer related fatigue and weakness as assessed by the following question: "Do you suffer from symptoms of fatigue and weakness related to your cancer or cancer treatment?"
- Have had cancer diagnosis and treatment in the past
- Must have a stable physical/health condition for the past 3 months with no expected changes for the duration of the study
- General Exclusion - All participants
- Neurological, psychiatric, musculoskeletal or other types of disorder not caused by cancer and/or cancer treatment, which may affect participants sensorimotor function and cognitive abilities
- No consciousness to understand and sign informed consent voluntarily
- History of alcohol, and illicit drug use
- History of smoking within the last 5 years.
- General Exclusion - Cancer Patients 1. Radiation, surgery, chemo, or other cancer treatment therapies in the past 6 months prior to enrollment. Hormonal maintenance treatment is allowed.
- General Exclusion - Healthy Participants
- 1\. History of cancer or cancer treatment
- Exclusion criteria related to tDCS and TMS safety - All participants
- History of epilepsy or unprovoked seizures
- Family history of epilepsy (father, mother, children, siblings with diagnosis of epilepsy)
- Active migraine headaches
- Past or current history of treated tinnitus or severe hearing problems
- Implanted medical devices (pacemakers, defibrillators, medical pump, implanted brain stimulator, aneurysm clip, carotid or cerebral stents, central venous catheter, non-removable hearing aids)
- Damage to the skin on the scalp
- History of mental illness (schizophrenia, anxiety, major depression, manic disorders)
- Tattoo with metal based ink in the head or neck
- Currently taking or withdrawing from any central nervous system active medication (stimulants, anticonvulsants, antidepressants, psychotropic medications).
- Pregnant as determined by a Pregnancy test for non-menopausal (no menstruation for at least 1 year) women younger than 55 years (for TMS and fMRI only).
- Exclusion criteria related to MRI safety - All participants
- We will be using the Kessler Foundation RONIC MRI center screening form to screen participants for the MRI scan. Exclusion criteria includes:
- Suffer from claustrophobia (fear of confined spaces)
- Prior injury to the eye involving a metallic object or fragment (e.g., metallic slivers, shavings, foreign body, etc.)?
- Presence or prior injury by a metallic object, or foreign body or metallic fragment (e.g., BB, bullet, shrapnel, etc.)
- Currently or former metal worker (welder, machinist, etc.)
- Implanted electrical devices (e.g. pacemakers, defibrillators or ICD)
- Implanted stimulators or internal electrodes or wires (neurostimulator, brain stimulator, spinal cord, bone growth/bone fusion)
- Aneurysm clips (metal clips on the wall of a large artery), metallic stent, shunt (spinal)
- Metallic prostheses or implants (including metal pins and rods, plate, screw, surgical staples, clips or metallic sutures, joint replacement (hip, knee), cochlear or other otologic implant, eye, penile, heart valves, eyelid spring or wires, prosthetic limbs)
- Dental implants, dentures or partial plates (regular filling, amalgam and crown are OK)
- Insulin, medication or other infusion pumps
- Radiation seeds or implants
- Transdermal medication patch (Nitroglycerine, Nicotine)
- IUD, diaphragm or pessary
- Tissue expander (e.g. breast)
- Body tattoos or permanent makeup (eyeliner, lip) if deemed unsafe in the MRI
- Body piercing
Exclusion
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07159100
Start Date
September 10 2025
End Date
December 31 2027
Last Update
September 8 2025
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052