tDCS for Cancer-Related Fatigue and Weakness

NCT ID: NCT07159100

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2027-12-31

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 design, participants perform fatiguing muscle tasks with and without tDCS, and outcomes include task endurance, maximal voluntary contraction force, and neuromuscular markers. Neural mechanisms will be assessed via EEG, TMS, and MRI.

Conditions

Cancer-related Fatigue; Neuromodulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active tDCS

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

Group Type: EXPERIMENTAL

Active tDCS + elbow flexion exercise

Intervention Type: DEVICE

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 20-30 minutes, either before or during a sustained submaximal isometric contraction task designed to induce fatigue.

tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current.

The intervention is unique as the target population is cancer survivors with persistent fatigue >6 months post-treatment. Also, the tDCS is combined with neurophysiological assessments, including EMG, TMS, EEG, and MRI, to provide neurophysiological evidence of acute effects.

Sham tDCS

Stimulation for 30 seconds with ramping to mimic active sensation.

Group Type: SHAM_COMPARATOR

Sham tDCS + elbow flexion exercise

Intervention Type: DRUG

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 30 seconds to mimic the sensation of active tDCS (20 minutes long), either before or during a sustained submaximal isometric contraction task designed to induce fatigue.

tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current.

Interventions

Active tDCS + elbow flexion exercise

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 20-30 minutes, either before or during a sustained submaximal isometric contraction task designed to induce fatigue.

tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current.

The intervention is unique as the target population is cancer survivors with persistent fatigue >6 months post-treatment. Also, the tDCS is combined with neurophysiological assessments, including EMG, TMS, EEG, and MRI, to provide neurophysiological evidence of acute effects.

Intervention Type: DEVICE

Sham tDCS + elbow flexion exercise

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 30 seconds to mimic the sensation of active tDCS (20 minutes long), either before or during a sustained submaximal isometric contraction task designed to induce fatigue.

tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current.

Intervention Type: DRUG

Other Intervention Names

Active tDCS

Eligibility Criteria

Inclusion Criteria

1. Aged 40-80

2. Right Handed, as determined by the Edinburgh Inventory 21

3. Proficient in English

4. Must be available for the familiarization, and testing sessions

General Inclusion - Cancer Patients only

1. Cancer (>6 months post therapy)

2. 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?"

3. Have had cancer diagnosis and treatment in the past

4. 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

1. 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

2. No consciousness to understand and sign informed consent voluntarily

3. History of alcohol, and illicit drug use

4. 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

1. History of epilepsy or unprovoked seizures

2. Family history of epilepsy (father, mother, children, siblings with diagnosis of epilepsy)

3. Active migraine headaches

4. Past or current history of treated tinnitus or severe hearing problems

5. Implanted medical devices (pacemakers, defibrillators, medical pump, implanted brain stimulator, aneurysm clip, carotid or cerebral stents, central venous catheter, non-removable hearing aids)

6. Damage to the skin on the scalp

7. History of mental illness (schizophrenia, anxiety, major depression, manic disorders)

8. Tattoo with metal based ink in the head or neck

9. Currently taking or withdrawing from any central nervous system active medication (stimulants, anticonvulsants, antidepressants, psychotropic medications).

10. 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).

1. Suffer from claustrophobia (fear of confined spaces)

2. Prior injury to the eye involving a metallic object or fragment (e.g., metallic slivers, shavings, foreign body, etc.)?

3. Presence or prior injury by a metallic object, or foreign body or metallic fragment (e.g., BB, bullet, shrapnel, etc.)

4. Currently or former metal worker (welder, machinist, etc.)

5. Implanted electrical devices (e.g. pacemakers, defibrillators or ICD)

6. Implanted stimulators or internal electrodes or wires (neurostimulator, brain stimulator, spinal cord, bone growth/bone fusion)

7. Aneurysm clips (metal clips on the wall of a large artery), metallic stent, shunt (spinal)

8. 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)

9. Dental implants, dentures or partial plates (regular filling, amalgam and crown are OK)

10. Insulin, medication or other infusion pumps

11. Radiation seeds or implants

12. Transdermal medication patch (Nitroglycerine, Nicotine)

13. IUD, diaphragm or pessary

14. Tissue expander (e.g. breast)

15. Body tattoos or permanent makeup (eyeliner, lip) if deemed unsafe in the MRI

16. Body piercing

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Guang Yue

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Yue, PhD

Role: STUDY_DIRECTOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Central Contacts

Leighann Martinez

Role: CONTACT

LMartinez@kesslerfoundation.org

973.324.3557

Vikram Shenoy Handiru, PhD

Role: CONTACT

vshenoy@kesslerfoundation.org

9733243578

Other Identifiers

R 1012-18

Identifier Type: -

Identifier Source: org_study_id