remotely supervised protocol for transcranial direct current stimulation to treat phantom limb pain

Treatment of Phantom Limb Pain by Remote Transcranial Direct Current Stimulation

The sensation of pain and discomfort experienced in an amputated limb and referred to as phantom limb pain (PLP) is a complex condition, challenging to treat, consisting of a refractory nature that contributes to the difficulty in achieving complete and long-lasting pain relief and management. The lack of effective treatment owing to its neuropathic nature, resulting from abnormal nerve activity, or signaling, neural plasticity, psychological factors, and limited understanding and research, influences the complexity of the phenomenon in the pain presentation and the treatment outcomes. From all available treatments, recent studies using transcranial direct current stimulation (tDCS) have reported positive results when combining stimulation of the primary motor cortex (M1) with motor representation techniques1,2,3,4. As Kikkert et al. published in 2019, the long-term effects of the combined stimulation resulted in significant, maintained pain reduction after intervention and a follow-up period of 3 months, with meaningful improvements and large effect sizes in lower-limb amputees.
Although the effects are promising, the clinical translations of these results are limited due to geographical constraints and disabilities related to amputations, which delay and affect the access to adequate post-amputation rehabilitation5. One solution is to deploy these interventions in remote environments using digital technologies and telehealth approaches6. A recent international consensus reported the requirements to successfully implement digitalized electrical stimulation7, including a support team available at all times to manage medical emergencies, cost optimization strategies, implementation of insurance coverage for further field development, specialized teams or third-party services for undertaking the development of software and hardware for the remote use of devices, digital marketing strategies to enhance publicity among potential patients, and front-end interfaces for user experience enhancement.
The adequate implementation of remotely supervised transcranial direct current stimulation (RS-tDCS) protocols has the potential to accelerate the clinical application of this safe and effective intervention4 and facilitate its combination with behavioral modalities that can be performed at home (e.g., physical therapy, mindfulness). Recent studies have shown feasibility and equivalent results with RS-tDCS compared to previous on-site tDCS studies for the same condition8,9. However, practical details and guidance on how to implement RS-tDCS for clinical trials in chronic pain are still limited in the literature. There are open questions on RS-tDCS such as the need for online supervision performed by a trained specialist in the technique compared to the self-administered tDCS therapy after receiving proper coaching. Furthermore, questions remain unanswered regarding metadata registration, adherence to the treatment guidelines, the use of technology such as apps to track contact quality and time of usage, avoiding the misuse of devices related to non-scheduled stimulation sessions, and topics associated with &#34;internet issues&#34;-protection of personal information, recording of health records, rules of sharing, and password protection for access.
Therefore, our goal is to provide a visual guideline on how to perform an RS-tDCS session, as well as a description of the logistics and challenges of its implementation for treating phantom limb pain (PLP) in the context of a pragmatic clinical trial.

Author Spotlight: Insights into Remotely Supervised Neuromodulation Procedure for Phantom Limb Pain

Using Home-based, Remotely Supervised, Transcranial Direct Current Stimulation for Phantom Limb Pain

From all available treatments, recent studies using transcranial direct current stimulation, tDCS, have reported positive results when combining stimulation of the primary motor cortex, M1, with motor representation techniques. The long-term effects of the combined stimulation resulted in significant, maintained pain reduction after intervention and a follow-up period of three months. Our goal is to provide a visual guideline on how to perform a remote supervised tDCS session, as well as a description of the logistics and challenges of its implementation for treating phantom limb pain, especially in the context of a pragmatic clinical trial.Another important contribution of this protocol is that most of the insights we are providing here can be translated to other studied population such as Parkinson's disease, traumatic brain injury, and post-stroke rehabilitation. Practical details and guidance on how to implement RS-tDCS for clinical trials on chronic pain are still limited in the literature, and they have the potential to accelerate the clinical application of the safe and effective intervention. And so on, facilitate its combination with the behavioral modalities that can be performed at home.This trial will provide significant insights in how to use remotely supervised neuromodulation. After this trial, we'll focus on improving the delivery and methodology of home-based devices to increase the reach and the use of neuromodulation techniques in rehabilitation. We think that by addressing these questions, the clinical use of neuromodulation will increase.

Remotely Supervised Protocol for Transcranial Direct Current Stimulation to Treat Phantom Limb Pain

remotely-supervised-protocol-for-transcranial-direct-current

Research

JoVE Journal

Neuroscience

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low-amplitude direct currents to alter cortical excitability. Previous trials have established the safety and tolerability of tDCS, and its potential to mitigate symptoms. However, the effects are cumulative, making it more difficult to have adherence to the treatment since frequent visits to the clinic or outpatient center are required. Moreover, the time needed for transportation to the center and the related expenses limit the accessibility of the treatment for many participants.
Following guidelines for remotely supervised transcranial direct current stimulation (RS-tDCS) implementation, we propose a protocol designed for remotely supervised and home-based participation that uses specific devices and materials modified for patient use, with real-time monitoring by researchers through an encrypted video conferencing platform. We have developed detailed instructional materials and structured training procedures to allow for self- or proxy-administration while supervised remotely in real time. This protocol has a specific design to have a series of checkpoints during training and execution of the visit. This protocol is currently in use in a large pragmatic study of RS-tDCS for phantom limb pain (PLP). In this article, we will discuss the operational challenges of conducting a home-based RS-tDCS session and show methods to enhance its efficacy with supervised sessions.

The goal of this study is to describe a protocol for the home-based delivery of remotely supervised transcranial direct current stimulation (RS-tDCS) conserving the standard procedures of in-clinic practice, including safety, reproducibility, and tolerability. The participants included will be patients with phantom limb pain (PLP).

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low-amplitude direct currents to alter cortical ...