Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Lymphosarcoma

Remotely delivered active tDCS + cognitive training

Remotely delivered sham tDCS + cognitive training

Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.

Active tDCS

Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.

Sham tDCS

Tara Brinkman, PhD

Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from conventional cognitive remediation approaches in that it directly stimulates specific brain regions responsible for cognitive processes and activates functional networks similar to those activated during cognitive training.

Primary Objective

To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on direct testing of executive function in survivors of ALL.

Secondary Objectives

* To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on patient-reported symptoms of executive dysfunction in survivors of ALL.
* To examine the effects of home-based tDCS paired with remote cognitive training on patterns of regional brain activation as measured by functional magnetic resonance imaging.
* To examine the effects of home-based tDCS paired with remote cognitive training on white matter integrity and structure as measured by diffusion tensor imaging.

Eligible participants will be randomized to receive 1 mA direct current stimulation over the left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will receive home-based computerized cognitive training. Participants will complete tDCS paired with cognitive training 2 times per week for 6-months.

Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

Digit Span Backward: Digit Span Backward (DSB), from the Digit Span subtest on the WAIS-IV, is a measure of working memory. The number of digits recalled in the longest span is converted to a standard z-score using age-based norms (Mean=0, SD=1).

Trail Making Test Part B (Trails B): This is a timed task that requires a participant to shift his/her attention adaptively and flexibly. Age-based standardized z-scores are calculated (Mean=0, SD=1).

Controlled Oral Word Association (COWA): This is a task of cognitive/verbal fluency that measures spontaneous production of words beginning with a designated letter or category. Age-based standardized z-scores are calculated (Mean=0, SD=1).

Patient reported symptoms of executive dysfunction will be evaluated via the Childhood Cancer Survivor Study Neurocognitive Questionnaire (CCSS-NCQ). The CCSS-NCQ is a 32-item questionnaire evaluating 4 domains of executive function. Z-scores (M=0, SD=1) are calculated using sibling data from the Childhood Cancer Survivor Study.

Patient reported symptoms of executive dysfunction will be evaluated via the Behavior Rating Inventory for Executive Function - Adult Version (BRIEF-A). The BRIEF-A is a 75-item measure of executive function that provides age- and sex-specific national normative data for nine domains of executive function (T-Score, M=50, SD=10).

White connectivity will be measured via diffusion tensor imaging and resting state fMRI (rsFMRI). The cortex will be parcellated into anatomical regions based on the high-resolution T1-weighted imaging using the FreeSurfer software (http://surfer.nmr.mgh.harvard.edu/). Probabilistic fiber tracking will be performed for individual seed points within the gray matter/white matter surface for each parcellated cortical region to evaluate strength of the connectivity between each individual region and every other region. The current project will focus analyses on the frontostriatal connections from the DLPFC to the striatum. rsfMRI data will be used to construct functional connectomes for each participant at each time point. We will measure several common connectome properties including global and local efficiency. Connectome modularity, degree distribution, and hub characteristics will also be measured.

Regional brain activation will be assessed using an N-Back Task. This task requires a participant to respond to a presented stimulus only when it is the same as one presented on a trial at a predetermined number prior to the current trial. For this study, we plan to use 1-back and 2-back trials. Improved efficiency will be defined as reduced activation in dorsolateral prefrontal cortex during performance on the N-Back task during the fMRI. Using Statistical Parametric Mapping software (SPM12, Wellcome Trust Centre for Neuroimaging, London), contrast-images from the fixed-effect analysis in each subject will be used for second level random-effect analysis to create group activation maps. These contrasts include pre- v. post-intervention imaging during the N-back task. Participants assigned to active stimulation will then be contrasted to those assigned to sham stimulation.

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Symptoms and General Pathology

Breast Neoplasms

Cognitive Dysfunction

Fatigue

Breast Diseases

Skin Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.

Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.

Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

tDCS

Sham Transcranial direct current stimulation (tDCS)..

Tracy D Vannorsdall, PhD

This study will test the preliminary efficacy of transcranial direct current stimulation (tDCS) to improve fatigue and cognition in women with a history of breast cancer and persistent fatigue.

Fatigue and cognitive dysfunction are commonly reported symptoms associated with impaired quality of life and productivity in breast cancer survivors. Transcranial direct current stimulation (tDCS) has been shown to improve both fatigue and cognition. Here tDCS will be used in a randomized, sham-controlled, double-blind, cross-over trial in women who have finished treatment of breast cancer and who report persistent fatigue.

Participants will complete measures of fatigue and cognition before and after five consecutive days of active or sham tDCS then complete questionnaires by phone one week later. Participants will return about one month later for another five days of participation, followed by another brief study phone call the following week.

Randomized, sham-controlled, double-blind, cross-over

Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation

Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline.

Change in subjective cognitive functioning as measured by the FACT-Cog Perceived Cognitive Impairment scale prior to and following the intervention. Raw scores range from 0 to 72, with higher scores reflecting better perceived cognitive functioning. Larger positive change scores reflect greater improvement in subjective cognitive functioning from baseline whereas greater negative change scores reflect declines in subjective cognitive functioning from baseline.

Change in subjective fatigue as measured by the MFSI-SF prior to and following the intervention. Raw scores range from -36 to + 144, with higher scores reflecting greater levels of fatigue. Larger positive change scores reflect greater improvement in fatigue from baseline whereas greater negative change scores reflect declines in fatigue from baseline.

Under Armour, Inc.

Johns Hopkins University

Adverse events related to the study intervention were recorded per the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS: Sham Transcranial direct current stimulation (tDCS)..

Active tDCS First

Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS: Sham Transcranial direct current stimulation (tDCS)..

Sham tDCS First

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Tracy Vannorsdall, PhD

2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS: Sham Transcranial direct current stimulation (tDCS).

Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS: Sham Transcranial direct current stimulation (tDCS).

Participants who completed both active and sham conditions, allowing for calculation and comparison of change by condition.

Change on Paced Auditory Serial Attention Test (PASAT)

Active tDCS (5 Days)

Sham tDCS (5 Days)

Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)

Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)

2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days. This condition is followed by an active tDCS condition after a washout.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS: Sham Transcranial direct current stimulation (tDCS).

Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days. This condition is followed by an active tDCS condition after a washout.

tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.

Sham tDCS: Sham Transcranial direct current stimulation (tDCS).

First Intervention (5 Days)

Washout (4 Weeks)

Second Intervention (5 Days)

Substance Related Disorders

Chemotherapy-Related Cognitive Impairment

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Anodal tDCS+ intensive cognitive Training

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).

Anodal tDCS

Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.

Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min

Intensive cognitive training

Agnes Flöel, Prof.

Daria Antonenko, Dr.

The aim of this study is to investigate whether a high definition tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in women with post-chemotherapy cognitive impairment after breast cancer treatment.

Patients who have undergone chemotherapy, may develop post-chemotherapy cognitive impairment (PCCI), which may occur in several cognitive domains and persist for many years. These declines in cognitive functions can lead to psychological distress and affect overall patients' quality of life. The goal of the present study is to assess behavioral effects of a multi-session cognitive training combined with high-definition transcranial direct current stimulation (tDCS) in women with PCCI. First studies have shown positive effects of cognitive training on trained and untrained functions and the subjective perception of stress, however the effects are small and transfer effects are inconsistent. A promising approach to elongate and increase the effects of cognitive training is to combine the training with tDCS. Therefore, in this study women with PCCI will participate in a three-week cognitive training with concurrent online high-definition tDCS application. Cognitive performance (primary), as well as Quality of Life scores and Sleep data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training intervention in women with PCCI in order to establish its potential to induce improvements in cognitive functions, and to beneficially affect patient-reported outcome measures.

Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment

Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment

Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task

Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task

Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task

PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)

Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.

Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)	NCT04007601	Acute Lymphobla...	Active tDCS Sham tDCS	18 Years - 39 Years	St. Jude Children's Research Hospital
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)	NCT04007601	Acute Lymphobla...	Active tDCS Sham tDCS	18 Years - 39 Years	St. Jude Children's Research Hospital
Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation	NCT03143894	Breast Cancer Cognitive Dysfu... Fatigue	tDCS Sham tDCS	18 Years -	Johns Hopkins University
Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation	NCT03143894	Breast Cancer Cognitive Dysfu... Fatigue	tDCS Sham tDCS	18 Years -	Johns Hopkins University
Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment	NCT04817566	Breast Cancer Cognitive Impai...	Anodal tDCS Sham tDCS Intensive cogni...	18 Years - 60 Years	University Medicine Greifswald

Spots Global Cancer Trial Database for sham tdcs

Every month we try and update this database with for sham tdcs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sham tdcs

Every month we try and update this database with for sham tdcs cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sham tdcs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.