Cancer-related FatigueEarly Phase 1NCT07159100
tDCS for Cancer-Related Fatigue and Weakness
A Early Phase 1 study testing Active tDCS + elbow flexion exercise in people with Cancer-related Fatigue and Neuromodulation, run by Kessler Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer-related Fatigue, Neuromodulation
- What is being tested?
- Active tDCS + elbow flexion exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kessler Foundation
West Orange, New Jersey, 07052
Vikram Shenoy Handiru, PhD
Easter Selvan Suviseshamuthu, PhD
About this study
Official title: Neuromodulation as a Therapeutic Intervention to Improve Cancer Related Fatigue and Weakness
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
- Being tested
- Active tDCS + elbow flexion exercise, Sham tDCS + elbow flexion exercise
- Keywords
- tDCS, Cancer-related fatigue, neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS + elbow flexion exerciseDevice
Also called Active tDCS
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 + elbow flexion exerciseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | 1.5-2.0 mA stimulation over motor cortex during fatigue task. Receives: Device: Active tDCS + elbow flexion exercise |
| Sham tDCS | Sham comparator | Stimulation for 30 seconds with ramping to mimic active sensation. Receives: Drug: Sham tDCS + elbow flexion exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue task duration
Duration (in seconds) that participants are able to maintain a submaximal isometric contraction (20-40% of maximal voluntary contraction) during a fatigue-inducing task, performed with and without transcranial direct current stimulation (tDCS).
Measured: Immediately post-intervention in each experimental session.
Muscle Strength
Peak muscle force (in Newtons) generated during a maximal voluntary contraction (MVC) of the arm muscles, assessed immediately before and after the fatiguing isometric contraction task. Comparison is made across active tDCS and sham conditions to determine the acute effects of neuromodulation on post-fatigue strength. Force is measured using a calibrated force sensor.
Measured: Immediately after each stimulation session
Secondary outcomes (4)
EMG root mean squared amplitude
RMS amplitude of surface EMG signals recorded from elbow flexor muscles during the fatigue task. This metric quantifies neuromuscular activity and is used to assess the change in motor unit recruitment from the start to the end of the fatiguing task. EMG is acquired concurrently with force data and compared across tDCS and sham sessions.
Measured: Immediately after each stimulation session
Interpolated Twitch Force (Peripheral Fatigue Index)
Amplitude (in Newtons) of superimposed twitch responses elicited by peripheral nerve stimulation at regular intervals during the fatigue task. This measure assesses muscle reserve and peripheral fatigue by comparing twitch force amplitude pre- and post-task. A reduction in twitch force reflects greater peripheral contribution to fatigue.
Measured: Immediately after each stimulation session
Motor Evoked Potential (MEP) Amplitude
Amplitude (in µV) of motor evoked potentials (MEPs) recorded via surface EMG in response to single-pulse TMS over the motor cortex. MEPs are measured at baseline and post-fatigue to assess changes in corticospinal excitability, and are compared across stimulation conditions (tDCS vs sham) and participant groups (cancer vs healthy controls)
Measured: Immediately after each stimulation session
EEG Functional Connectivity
Change in EEG functional connectivity within the motor network (primary motor cortex, premotor, supplementary motor, and somatosensory cortices) from pre- to post-fatigue states. EEG is recorded using a 64-channel cap and analyzed using EEGLAB-based pipelines to quantify connectivity changes via measures such as coherence or phase-locking value.
Measured: Immediately after each stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start10 Sep 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Yue, Kessler Foundation
- Investigators
- Guang Yue, PhD, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159100
- Sponsor's protocol ID
- R 1012-18
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation as a Therapeutic Intervention to Improve Cancer Related Fatigue and Weakness
- ClinicalTrials.gov ID
- NCT07159100
- Acronym / sponsor ID
- R 1012-18
- Conditions
- Cancer-related Fatigue, Neuromodulation
- Keywords
- tDCS, Cancer-related fatigue, neuromodulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCS + elbow flexion exercise1.5-2.0 mA stimulation over motor cortex during fatigue task. |
| Sham tDCS | Sham comparator | Drug: Sham tDCS + elbow flexion exerciseStimulation for 30 seconds with ramping to mimic active sensation. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCS + elbow flexion exerciseAlso: Active tDCSParticipants 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. | Device | Active tDCS |
| Sham tDCS + elbow flexion exerciseParticipants 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. | Drug | Sham tDCS |
Primary outcome
Fatigue task duration
Time frame: Immediately post-intervention in each experimental session.
Duration (in seconds) that participants are able to maintain a submaximal isometric contraction (20-40% of maximal voluntary contraction) during a fatigue-inducing task, performed with and without transcranial direct current stimulation (tDCS).
Muscle Strength
Time frame: Immediately after each stimulation session
Peak muscle force (in Newtons) generated during a maximal voluntary contraction (MVC) of the arm muscles, assessed immediately before and after the fatiguing isometric contraction task. Comparison is made across active tDCS and sham conditions to determine the acute effects of neuromodulation on post-fatigue strength. Force is measured using a calibrated force sensor.
4 secondary outcomes
EMG root mean squared amplitude
Time frame: Immediately after each stimulation session
Interpolated Twitch Force (Peripheral Fatigue Index)
Time frame: Immediately after each stimulation session
Motor Evoked Potential (MEP) Amplitude
Time frame: Immediately after each stimulation session
EEG Functional Connectivity
Time frame: Immediately after each stimulation session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guang Yue, PhD study director
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Active tDCS + elbow flexion exercise in people with Cancer-related Fatigue and Neuromodulation, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leighann Martinez (973.324.3557, LMartinez@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue task duration (time frame: Immediately post-intervention in each experimental session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.