Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)



Status:Recruiting
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:10/7/2018
Start Date:February 7, 2017
End Date:December 2019
Contact:Kathleen Sherman
Email:kathleen.sherman@nyumc.org
Phone:646 501 7531

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The proposed study will test the feasibility and tolerability of transcranial direct current
stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 60 cognitive
remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to
4.0 mA, dorsolateral prefrontal cortex or montage dependent on specific area of deficit)
while they complete the cognitive training tasks.

Transcranial Direct Current Stimulation (tDCS) is a novel, safe, well-tolerated, and low-cost
treatment approach that may enhance the benefits of cognitive remediation. The application of
tDCS is a relatively recent therapeutic development that utilizes low amplitude direct
currents to induce changes in cortical excitability. To meet this study's objectives,
investigators will focus specifically on working memory (WM) in both training and outcome.
Limiting training to WM exercises will provide the opportunity to test proof of concept for
the combined therapies within this shorter two-week time frame, and maximize the synergistic
effect by engaging the same regions as targeted by the tDCS.

Inclusion Criteria:

- At least 18 years of age

- Clinician Referral for cognitive remediation.

- Have undergone a neurological examination and neuropsychological examination as part
of standard of care.

- Has access to internet service at home compatible with the study laptop (Wi-Fi or
ethernet cable)

- Able to commit to the designated period of study training sessions with baseline and
follow-up visits.

- Able to understand the informed consent process and provide consent to participate in
the study

Exclusion Criteria:

- Visual, auditory and motor deficits that would prevent full ability to understand
study instructions or operate the tDCS device or study laptop, as judged by treating
clinician or study staff

- Primary, uncontrolled psychiatric disorder that would influence ability to participate

- Poorly controlled epilepsy

- Medical device implanted in the head (such as Deep Brain Stimulator) or in the neck
(such as a Vagus Nerve Stimulator)

- Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds,
burn including sunburns, cuts or irritation, or other skin defects which compromise
the integrity of the skin at or near stimulation locations (where electrodes are
placed)

- Treatment for a communicable skin disorder currently or over the past 12 months

- Other serious uncontrolled medical condition (e.g., cancer or acute myocardial
infarction)

- Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score <85*

- Symbol Digit Modalities Test (SDMT) ≥3.0 SD below published norms*

- Learned English language after 12 years of age

- Pregnant or breastfeeding

- In the case of the potential participant having either speech, motor or vision
impairment secondary to their condition that will limit the completion of the
SDMT and WRAT-4 screening measures the substitutions as mentioned above will be
used.
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Leigh Charvet, MD
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mi
from
New York, NY
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