tDCS for Cancer-Related Fatigue

Overseen By Leighann Martinez

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Kessler Foundation

Must not be taking: Stimulants, Anticonvulsants, Antidepressants, Psychotropics

Disqualifiers: Epilepsy, Migraines, Mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people who feel tired and weak after cancer treatment. It uses a technique called tDCS, a gentle form of brain stimulation, to see if it can boost energy levels and improve muscle strength. Participants will perform muscle tasks with both real and placebo tDCS to compare results. Individuals who underwent cancer treatment over six months ago and still feel tired or weak might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to experience this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial requires that you are not currently taking or withdrawing from any medications that affect the central nervous system, like stimulants, anticonvulsants, antidepressants, or psychotropic medications. If you are on such medications, you may need to stop taking them to participate.

What prior data suggests that tDCS is safe for alleviating cancer-related fatigue?

Research shows that transcranial direct current stimulation (tDCS) is generally safe. Studies have found that tDCS can reduce tiredness in stroke patients, improve movement, and ease daily activities. These studies reported no major safety problems.

Additionally, tDCS has been used in various situations, such as reducing anxiety and aiding sleep, without significant side effects. Since this is an early-phase trial for cancer-related fatigue, the main goal is to test the treatment's safety. Early-phase trials usually focus on ensuring the treatment is well-tolerated.

Overall, current evidence suggests tDCS is safe, but discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about transcranial direct current stimulation (tDCS) for cancer-related fatigue because it offers a non-invasive way to potentially boost energy levels. Unlike traditional treatments, which often involve medication or lifestyle changes, tDCS delivers a mild electrical current directly to the brain's motor cortex. This approach may help improve fatigue by directly targeting brain activity, offering a unique mechanism of action compared to existing therapies. Plus, the procedure is quick and relatively simple, which could make it a more convenient option for patients.

What evidence suggests that tDCS is effective for cancer-related fatigue?

Research shows that transcranial direct current stimulation (tDCS) might alleviate cancer-related fatigue. Many studies have demonstrated that tDCS reduces fatigue in numerous individuals. It also appears to enhance focus and reduce anxiety, potentially boosting overall energy. In this trial, participants will receive either active tDCS or sham tDCS to assess its effectiveness. While these results are encouraging, some studies suggest that tDCS might not always outperform other treatments. Most people find tDCS safe, with only mild side effects. ^{1 3 5 6 7}

Who Is on the Research Team?

Guang Yue, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals experiencing cancer-related fatigue and muscle weakness. Participants should be able to perform specific muscle tasks and undergo brain stimulation procedures. The exact inclusion criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Participants must be right-handed as determined by the Edinburgh Inventory 21

Participants must be proficient in English

My health has been stable for the last 3 months and is expected to remain so.

Exclusion Criteria

Participants with a history of epilepsy or unprovoked seizures

Participants with implanted medical devices

Participants with a history of mental illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform fatiguing muscle tasks with and without tDCS, with outcomes including task endurance, maximal voluntary contraction force, and neuromuscular markers.

Duration not specified

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests if non-invasive brain stimulation (tDCS) combined with elbow flexion exercises can reduce fatigue and strengthen muscles in people with cancer-related symptoms. It's a pilot study using a randomized, double-blind crossover design to compare active tDCS against sham (placebo) treatment.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

1.5-2.0 mA stimulation over motor cortex during fatigue task.

Group II: Sham tDCS Placebo Group 1 Intervention

Stimulation for 30 seconds with ramping to mimic active sensation.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07159100

tDCS for Cancer-Related Fatigue and Weakness This pilot study investigates the effectiveness of non-invasive brain stimulation (tDCS) in alleviating cancer-related fatigue (CRF) and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7446233/

Impact of transcranial direct current stimulation on ... Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer- ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817813

Transcranial Direct Current Stimulation for Anxiety During ... In addition, this study found that the active tDCS mode may significantly reduce anxiety, alleviate pain, improve sleep quality, as well as ...

4. nature.com nature.com/articles/s41598-025-88255-2

Home-based transcranial direct current stimulation paired ... Both groups showed significant reductions in fatigue, with no significant difference between them. This suggests that tDCS does not provide any ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1297429/full

Study protocol of a double-blind randomized control trial ... In 36 out of 42 (85.7%) of studies reported an improvement in fatigue scores in the tDCS group. Side effects of tDCS are usually mild (42). Hence tDCS proves to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8519229/

A randomized controlled trial to explore the efficacy and safety ... TDCS is a safe treatment that can effectively reduce the degree of fatigue after stroke, improve the motor function and daily activity ability of patients ...

7. withpower.com withpower.com/trial/early-phase-1-neuromodulation-8-2025-e916f

tDCS for Cancer-Related Fatigue · Info for Participants This pilot study investigates the effectiveness of non-invasive brain stimulation (tDCS) in alleviating cancer-related fatigue (CRF) and muscle weakness.