Objective Background - PowerPoint Presentation

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Objective

Background

Results

Conclusions

Research supported by The Lourie Center, Inc.

The remotely supervised methods proved to be an effective and well-tolerated means of providing access to patients with a range of disability, especially those with more advanced form of the disease (76% progressive). tDCS can improve cognitive processing, fatigue and other aspects of symptomatic management in MS.Low positive affect scores at baseline may mediate treatment response to tDCS

To evaluate the clinical efficacy of remotely-supervised tDCS in multiple sclerosis (MS).

Transcranial direct current stimulation (tDCS) refers to the delivery of mild electrical stimulation through electrodes placed on the scalp. It is thought to enhance cortical excitability. tDCS has the potential for symptomatic management in MS.  However, repeated sessions are necessary in order to adequately evaluate a therapeutic effect.  It is not feasible for many individuals with MS to visit clinic for treatment on a daily basis, and clinic delivery is also associated with substantial cost.  Prior work has established the feasibility and reproducibility of a remotely-supervised tDCS protocol in MS.

Through a highly controlled, remotely-supervised tDCS protocol (accessed by patients from home and monitored through a web conferencing software), we compared the preliminary clinical efficacy observed following tDCS (active tDCS + cognitive training) in MS to a control condition (cognitive training only) and included those with both relapsing remitting and progressive subtypes.  Active participants were enrolled in a methods study and completed ten x 20 minute x 1.5 mA sessions combined with working memory exercises while control participants completed cognitive training only following the same remotely-supervised protocol. In the active condition, the baseline measures were collected in clinic followed by the presentation of the tDCS study kit (Figure 1), an instructional video on the tDCS device, study laptop and daily study procedures. Additional instruction was provided to confirm understanding of each participant and/or proxy. The first self-guided tDCS session was then completed in clinic. On day two of the study, study technicians delivered the equipment to the participant’s home, confirmed environmental suitability, and observed the second self guided session, providing training where necessary. In the control condition, the baseline measures were collected in clinic followed by presentation of the study laptop, and an introduction to the cognitive training exercises.

A total of 45 participants completed the study, n=25 for the active condition and n=20 for controls. Participants ranged in age from 29 to 69 years and included both relapsing remitting and progressive subtypes, with mild to more severe disability (Expanded Disability Status Scale or EDSS scores ranging from 1.0 to 8.0).

2 daily labeled saline syringes per day (6mL per sponge pocket)

Space to store headset, device, and cables

Handheld mirror for participant to adjust headset location

2 sponge pockets per day, each with an easy to tear perforation at the top

Extra saline solution to optimize contact quality

Device holder to position device more conveniently while utilizing study laptop

Device kit to store all equipment and materials

Figure 1.

Active condition tDCS

study kit

References

Methods

1. Charvet LE, Kasschau M, Datta A, et al. Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials:

guidelines

for technology and protocols.

Front Syst Neurosci.

2015;9:26.

2. Kasschau M, Sherman K, Haider L, et al. A Protocol for the Use of Remotely-Supervised Transcranial Direct Current

Stimulation

(tDCS) in Multiple Sclerosis (MS). J Vis Exp. 2015(106).3.. Kasschau M., Reisner J., Sherman K., Bikson M., Datta A., Charvet L.E. 2016. Transcranial Direct Current Stimulation Is Feasible for Remotely Supervised Home Delivery in Multiple Sclerosis. Neuromodulation. 2016

At-home Transcranial Direct Current Stimulation (tDCS) Improves

Cognitive Processing Speed and Fatigue in Multiple Sclerosis (MS)

M Kasschau1, K Sherman1, A Frontario1, M Bikson2, A Datta3, L Charvet11NYU Langone Medical Center Department of Neurology 2The City College of New York Department of Biomedical Engineering 3Soterix Medical Inc.

The treatment was well-tolerated in both conditions with 95% compliance in the active condition, and 100% compliance in the control group.Following the treatment period the active group had greater improvement on measures of cognitive functioning (Figures 2,3), self-reported mood (Figure 4), and fatigue (Figure 5) from baseline compared to the control group.  

Participants in both conditions were remotely-supervised through VSee, a telemedicine software program, to confirm headset placement (active condition), and collect daily inventories of pain, mood, fatigue, and any other side effects. Mood and fatigue inventories (PROMIS) and cognitive processing speed (Attention Network Test- Interaction intra-individual variability or IIV, Cogstate) were collected at baseline and follow-up.

Table 1. Demographic and Clinical Characteristics CharacteristicFull Sample (n=45)tDCS + Cognitive Training(n=25)Cognitive Training Only(n=20)Gender (% Female)75.56%84.00%65.00%Age (mean years)51.96±11.0052.69±9.4951.00±12.71Education (Years)15.59±2.4316.15±2.5514.85±2.01Disease Duration (mean years)17.21± 9.3118.41±8.8915.9±9.60EDSS (median, range)4.0 (1.0-8.0)4.87±2.054.38±1.79

Table 2. Effect Size Magnitude with Low Positive Affect TestCohen’s dLow PA Cohen’s dOne-Back (ONB)0.580.97Choice RT (IDN)0.570.90IIV in RT0.481.79Mood/Affect0.360.64Fatigue0.280.78

In the active condition, baseline positive affect mediated treatment response with lower baseline level associated with greater magnitude of improvement across the symptoms measured (Table 2).

Figure 2. Changes on Computerized Reaction Time (Identification and One-back) Measures Following Active

tDCS v.

Control

Figure

5. Change in PROMIS Fatigue Score Following Active tDCS v. Control

Figure 3. Changes in Cognitive Response Time (IIV) Following Active tDCS vs. Control

Figure 4. Change in PROMIS Positive Affect Score Following Active tDCS v. Control