tDCS for Cancer-Related Fatigue and Weakness

Not Applicable

Not yet recruiting

• Conditions: Cancer-related Fatigue; Neuromodulation
• Interventions: Device: Active tDCS + elbow flexion exercise; Drug: Sham tDCS + elbow flexion exercise

• Registration Number: NCT07159100
• Lead Sponsor: Kessler Foundation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-09-10
• Primary Completion: 2027-08-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active tDCS	Active tDCS + elbow flexion exercise	1.5-2.0 mA stimulation over motor cortex during fatigue task.
Sham tDCS	Sham tDCS + elbow flexion exercise	Stimulation for 30 seconds with ramping to mimic active sensation.

Primary Outcome Measures

Name	Time	Method
Fatigue task duration	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	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.

Secondary Outcome Measures

Name	Time	Method
Interpolated Twitch Force (Peripheral Fatigue Index)	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.
EEG Functional Connectivity	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.
EMG root mean squared amplitude	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.
Motor Evoked Potential (MEP) Amplitude	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)

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States