Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks.

Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks.

Repetitive Transcranial Magnetic Stimulation (rTMS)

Mehmet Dokucu, MD, PhD

Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is associated with high rates of depression and anxiety among its sufferers, and cancer patients with depression usually have worse treatment outcomes and long-term survival. Surprisingly, many cancer patients with depression do not receive treatment for their depression, perhaps because treatments for cancer-related depression are usually adapted from those used in non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients with depression are more likely to have a long latency of anti-depressant drug action, negative drug-drug interactions with cancer chemotherapies and an increased susceptibility for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new treatment modality for depression that affects the brain directly with no systemic side effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder, and now is being evaluated for a wide array of additional psychiatric indications. This randomized, open label, two-arm, pilot study will investigate the safety, tolerability, feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly reduce symptoms of depression and that right-sided slow rTMS will be more effective than left-sided fast rTMS for the treatment of severe anxiety.

Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety

A Randomized Open-Label Pilot Trial To Evaluate The Safety And Efficacy Of Repetitive Transcranial Magnetic Stimulation In Cancer Patients With Depression And Anxiety

Overall change in depression severity (as measured by the Hamilton Depression Rating Scale) will be measured for each treatment arm.

Change in depression severity (as measured by the Hamilton Depression Rating Scale) for a treatment arm will be compared relative to change in depression severity in the other treatment arm.

At weeks 2, 4 and 6, UKU Side Effects Rating Scale scores will be compared to baseline UKU scores to determine changes in presence and severity of side effects. Additionally, UKU scores at weeks 2, 4, and 6 will be used to determine probability that side effects are related to intervention.

Overall change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be measured for each treatment arm.

Change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) for a treatment arm will be compared relative to change in anxiety severity in the other treatment arm.

Baseline anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be correlated with change (from baseline to end of week 6) in depression severity (as measured by the Hamilton Depression Rating Scale) for each treatment arm and compared.

Baseline anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be correlated with Harm Avoidance scores from the TCI personality inventory

Neuronetics

Northwestern University

Assistant Professor of Psychiatry

Nervous System Diseases

Symptoms and General Pathology

Peripheral Nervous System Diseases

Pain

Neuromuscular Diseases

The real rTMS will be delivered over M1 (hand representation) of dual hemispheres with 10 trains of 10 Hz pulses for 10 seconds, with a total of 1,000 pulses per hemisphere. The real rTMS intensity will be set as 80% resting motor threshold and the interval between each train of pulses will be set as 50 seconds. The real rTMS will be delivered as daily session for five consecutive days, followed by two fortnightly maintenance sessions during the follow-up period after the completion of five daily sessions. The real rTMS will be delivered by designated physical therapists using "figure-of-8" shaped coil.

Real repetitive transcranial magnetic stimulation

The sham rTMS of this study will be delivered with the same active coil angled 90-degree way from the scalp. The intensity of sham rTMS will be set at lowest stimulator output that can generate similar noise to the real rTMS. The sham rTMS will be delivered in the same manner and duration with real rTMS.

Sham repetitive transcranial magnetic stimulation

Alex Molassiotis, PhD

Mian Wang, MN

The study aims to evaluate the feasibility of a repetitive transcranial magnetic simulation (rTMS) protocol developed for managing pain and other related symptoms associated with chemotherapy-induced peripheral neuropathy in cancer patients.

A total of 60 cancer patients who are aged 18 years or above and have persistent peripheral neuropathy for at least 3 months after completion of oxaliplatin-, paclitaxel-, or docetaxel-based chemotherapy will be recruited. After randomization, the experimental group (n = 30) will receive high-frequency rTMS, while the control group (n = 30) will receive sham rTMS. The rTMS will be delivered over M1 (hand representation) of dual hemispheres with 10 trains of 10 Hz pulses for 10 seconds, with a total of 1,000 pulses per hemisphere. The rTMS intensity will be set as 80% resting motor threshold and the interval between each train of pulses will be set as 50 seconds. The rTMS will be delivered as daily session for five consecutive days, followed by two fortnightly maintenance sessions during the follow-up period after the completion of five daily sessions. The rTMS will be delivered by designated physical therapists using "figure-of-8" shaped coil connected to an electromagnetic stimulator in the rehabilitation therapy room of the study hospitals in mainland China.

The research outcomes are feasibility (1. recruitment: i.e. the length of time spent on recruiting participants, the mean number of participants been recruited each month, and the proportion of eligible patients who are finally recruited in the study; 2. eligibility: the proportion of screened patients meeting the inclusion criteria; 3. retention and attrition rates: the proportion of recruited participants who complete the study or who drop out from the study with or without any reason; and 4. appropriateness of clinical outcome measures: the proportion of incomplete questionnaires and neurological tests, as well as the characteristics of the missing data.), acceptability (Chinese version of the Patients' Global Impression of Change \[PGIC\] scale), safety, and trend of improvement in pain, other related symptoms, and quality of life by rTMS in cancer patients with CIPN.

Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy

Evaluating the Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy: A Randomized Feasibility Study

The proportion of screened patients meeting the inclusion criteria.

The mean number of participants been recruited each month.

The proportion of eligible patients who are finally recruited in the study.

The proportion of recruited participants who complete the study or who drop out from the study with or without any reason.

The proportion of incomplete questionnaires and neurological tests.

In this study, affective attitude and perceived effectiveness will be measured by using the Chinese version of the Patient Global Impression of Change (PGIC) scale, a single-item 7-point numerical rating scale from 1 to 7 demonstrating participants' subjective perception of improvement and satisfaction after receiving the intervention (Hurst \& Bolton, 2004). The PGIC scale has been recommended by the rTMS research guideline for pain (Klein et al., 2015).

The Chinese version of the Brief Pain Inventory (BPI) will be used to assess pain associated with CIPN. This instrument was developed and validated by Wang et al. (2009) for measuring severity (four scales) and interference (seven scales) of pain in cancer patients, which demonstrated good internal consistencies of both domains (Cronbach's α were 0.894 and 0.915, respectively).

Total Neuropathy Score-nurse© (TNSn©) is a validated instrument to evaluate symptoms and signs associated with CIPN based on both patient-reported and clinician-assessed data including three symptom questions (distribution areas of numbness, tingling/paresthesias, and neuropathic pain) and testing of vibration and pinprick; each of the symptoms and signs is scored from 0 to 4, with higher score indicating worse condition (Smith, Cohen, Pett \& Beck, 2010).

The Chinese version of Edmonton Symptom Assessment System (C-ESAS) validated by Dong et al. (2015) will be used to explore whether the intervention would bring any change in the concurrently reported symptoms among cancer patients including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and potential miscellaneous symptoms that are not listed. Cronbach's α of the C-ESAS was 0.72, indicating an acceptable internal consistency.

Functional Assessment of Cancer Therapy-General questionnaire (FACT-G), a widely used self-reported questionnaire measuring health-related quality-of-life (QoL) in cancer patients, will be used in this study. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx) will be used to measure the participants' CIPN specific quality of life in this study. It is an 11-item tool added to the FACT measurement system for assessing cancer patients' symptoms and interference induced by neuropathy, which includes sensory, motor, and hearing problems, as well as dysfunctions associated with neuropathy. Good psychometrical properties of the FACT/GOG-Ntx have been demonstrated.

To determine the safety of rTMS in this population, participants will be asked to report any adverse effect occur during the study. The adverse effects, including the type, occurrence, and duration, will be recorded using a standard form. According to the guidelines (Klein et al., 2015; Rossi et al., 2009), the potential adverse effects associated with rTMS are transient seizures, headaches, transient hearing changes, local pain, neck pain, toothache, and paresthesia. These potential adverse effects will be listed in the standard form, and will be filled out by the designated therapists based on their observation and the participants' self-report after each treatment session. If any adverse effect occurs but is not listed in the form, the therapist will record the condition in the "Other" column.

The Hong Kong Polytechnic University

Neoplasms

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.

Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo sham repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.

Participate in home-based walking program

Physical Activity

Questionnaire Administration

Repetitive Transcranial Magnetic Stimulation

Sham Intervention

Christine Sheffer

This trial studies how well a home-based walking program, with or without repetitive transcranial magnetic stimulation, works in helping breast cancer survivors get more physical activity. Physical activity has been shown to improve health outcomes and quality of life among breast cancer survivors and can help lessen certain side effects of treatment such as fatigue, depression, and treatment-related weight gain. Repetitive transcranial magnetic stimulation is a procedure that uses electromagnets to stimulate brain activity. Using rTMS with a home-based walking program may help breast cancer survivors get more physical activity.

PRIMARY OBJECTIVES:

I. To examine the effects of 20 hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) on delay discounting rates and multiple measures of self-regulation and walking.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.

GROUP II: Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo sham repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.

A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity

Enhancing A Home-Based Walking Intervention Among Breast Cancer Survivors With rTMS: Feasibility and Limited Efficacy Testing

The effect of the transcranial magnetic stimulation (TMS) intervention on the delay discounting score will be assessed using a two-arm, randomized, double-blind, sham controlled repeated measures design. The efficacy of TMS will be quantified by comparing the within-patient change in delay discounts scores between the baseline and week 12 assessments in the evaluable sample. The treatment effect will be estimated with a generalized linear mixed model, describing the continuous delay discounting outcomes as a function of a random participant effect, and fixed effects for treatment assignment (TMS reference: sham), categorical visit number (4 levels), and the treatment/visit interaction. The magnitude, direction and 95% confidence interval for the adjusted interaction term estimate will be used to describe the effect of TMS on the delay discounting score. These results will be supported by descriptive statistics and graphical depictions of the results as appropriate.

The effects of TMS on steps per day will be quantified by comparing the within-patient change in these outcomes between the baseline and week 12 assessments in the evaluable sample. The treatment effect will be estimated with a generalized linear mixed model as described above. These results will be supported by descriptive statistics and graphical depictions of the results as appropriate. This analysis will be used to determine the feasibility of using rTMS to enhance a home-based walking intervention among breast cancer survivors, based on whether breast cancer survivors who receive active rTMS demonstrate more steps per day than breast cancer survivors who receive sham rTMS.

The effects of TMS on minutes of activity per week will be quantified by comparing the within-patient change in these outcomes between the baseline and week 12 assessments in the evaluable sample. The treatment effect will be estimated with a generalized linear mixed model as described above. These results will be supported by descriptive statistics and graphical depictions of the results as appropriate. This analysis will be used to determine the feasibility of using rTMS to enhance a home-based walking intervention among breast cancer survivors, based on whether breast cancer survivors who receive active rTMS demonstrate more minutes of moderate intensity activity than breast cancer survivors who receive sham rTMS.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety	NCT01701284	Cancer in Remis... Depression Anxiety	Repetitive Tran...	22 Years - 80 Years	Northwestern University
Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy	NCT04107272	Chemotherapy-in...	Real repetitive... Sham repetitive...	18 Years -	The Hong Kong Polytechnic University
A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity	NCT03789877	Cancer Survivor Invasive Breast...	Physical Activi... Questionnaire A... Repetitive Tran... Sham Interventi...	18 Years - 64 Years	Roswell Park Cancer Institute
Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety	NCT01701284	Cancer in Remis... Depression Anxiety	Repetitive Tran...	22 Years - 80 Years	Northwestern University
Use of Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy	NCT04107272	Chemotherapy-in...	Real repetitive... Sham repetitive...	18 Years -	The Hong Kong Polytechnic University

Spots Global Cancer Trial Database for repetitive transcranial magnetic stimulation