Kessler Foundation
West Orange, New Jersey, 07052, United States
Location contact
Easter Selvan Suviseshamuthu, PhD
SUB_INVESTIGATOR
Guang Yue, PhD
PRINCIPAL_INVESTIGATOR
Vikram Shenoy Handiru, PhD
SUB_INVESTIGATOR
NCT Number: NCT07159100
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.
Trial opening soon.
Get Notified40 year–80 year
All sexes
Interventional
Early Phase 1
West Orange, New Jersey, 07052, United States
Easter Selvan Suviseshamuthu, PhD
SUB_INVESTIGATOR
Guang Yue, PhD
PRINCIPAL_INVESTIGATOR
Vikram Shenoy Handiru, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
General Inclusion - All participants
General Inclusion - Cancer Patients only
General Exclusion - All participants
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
Exclusion criteria
related to tDCS and TMS safety - All participants
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:
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.
Other names: 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 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.
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).
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.
Time frame: Immediately after each stimulation session
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.
Time frame: Immediately after each stimulation session
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.
Time frame: Immediately after each stimulation session
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)
Time frame: Immediately after each stimulation session
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.
Contact information is provided by the study sponsor or research team.
Leighann Martinez
CONTACT
Vikram Shenoy Handiru, PhD
CONTACT
Kessler Foundation
Other
Neuromodulation as a Therapeutic Intervention to Improve Cancer Related Fatigue and Weakness
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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