tDCS for Cancer-Related Fatigue and Weakness
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorKessler Foundation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 40-80
Right Handed, as determined by the Edinburgh Inventory 21
Proficient in English
Must be available for the familiarization, and testing sessions
Disqualifiers
History of epilepsy or unprovoked seizures
Family history of epilepsy (father, mother, children, siblings with diagnosis of epilepsy)
Active migraine headaches
Past or current history of treated tinnitus or severe hearing problems
Trial design
Design model
Crossover
Treatments tested in this trial
Active tDCS + elbow flexion exercise
DeviceParticipants 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 exercise
DrugParticipants 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.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Immediately post-intervention in each experimental session.2
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.
Time frame
Immediately after each stimulation sessionSecondary outcomes
1
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.
Time frame
Immediately after each stimulation session2
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.
Time frame
Immediately after each stimulation session3
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)
Time frame
Immediately after each stimulation session4
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.
Time frame
Immediately after each stimulation sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: