Multiple SclerosisNCT03049969
Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
A study testing tDCS stimulation in people with Multiple Sclerosis and Neurological Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Neurological Disorder
- What is being tested?
- tDCS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 26 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Medical Center
New York, New York, 10016
About this study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, Neurological Disorder
- Being tested
- tDCS stimulation
- Keywords
- Working Memory, Cognitive Training, Transcranial Magnetic Stimulation
- Medical subject headings
- Multiple Sclerosis, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulationDevice
Also called Soterix Mini-CT
up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation | Experimental | For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed. Receives: Device: tDCS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step
Measured: End of treatment (up to 12 weeks)
Number of Participants With Treatment Related Adverse Events
Measured: End of treatment (up to 12 weeks)
Secondary outcomes (4)
Change in Visual Analogue Scale (VAS) for Pain Score
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Baseline, end of treatment (up to 12 weeks)
Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS)
This brief scale is comprised of 10 items measuring negative affect (e.g., upset, afraid). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The negative affect score is calculated by finding the sum of the 10 negative items. Scores range from 10 - 50. For the total negative score, a lower score indicates less of a negative affect.
Measured: Baseline, end of treatment (up to 12 weeks)
Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS)
This brief scale is comprised of 10 items measuring positive affect (e.g., excited, inspired). Individual items are scored 1-5, 1 being "very slightly or not at all" and 5 being "Extremely". The positive affect score is calculated by finding the sum of the 10 positive items. Scores range from 10 - 50. For the total positive score, a higher score indicates more of a positive affect.
Measured: Baseline, end of treatment (up to 12 weeks)
Change in Symbol Digit Modalities Test (SDMT) Score
The SDMT is a cognitive processing speed test. Participants are given a key of nine symbol-digit pairs along with a sequence of symbols. They are then asked to use the key to match as many symbols in the sequence to their corresponding numbers as possible within 90 seconds. The score is the number of correctly coded items from 0-110 in 90 seconds. Lower scores indicate cognitive decline.
Measured: Baseline, end of treatment (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start7 Feb 2017
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Why it stopped: New controlled trial was funded, this study was no longer needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 sessions of cognitive remediation while receiving 20 minutes of up to 2.0 mA tDCS using a DLPFC montage
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, MD, Principal investigator, New York University Medical Center Institutional Review Boards
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049969
- Sponsor's protocol ID
- 16-01810
- Status last verified
- Jun 2024
- First submitted
- 8 Feb 2017
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Pilloni G, Shaw M, Feinberg C, Clayton A, Palmeri M, Datta A, Charvet LE. Long term at-home treatment with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report. J Neuroeng Rehabil. 2019 Mar 19;16(1):41. doi: 10.1186/s12984-019-0514-z.
PubMed 30890162
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT03049969
- Acronym / sponsor ID
- 16-01810
- Conditions
- Multiple Sclerosis, Neurological Disorder
- Keywords
- Working Memory, Cognitive Training, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New controlled trial was funded, this study was no longer needed.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 sessions of cognitive remediation while receiving 20 minutes of up to 2.0 mA tDCS using a DLPFC montage
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation | Experimental | Device: tDCS stimulationFor the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS stimulationAlso: Soterix Mini-CTup to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks | Device | Cognitive Remediation |
Primary outcome
Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
Time frame: End of treatment (up to 12 weeks)
The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step
Number of Participants With Treatment Related Adverse Events
Time frame: End of treatment (up to 12 weeks)
4 secondary outcomes
Change in Visual Analogue Scale (VAS) for Pain Score
Time frame: Baseline, end of treatment (up to 12 weeks)
Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, end of treatment (up to 12 weeks)
Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, end of treatment (up to 12 weeks)
Change in Symbol Digit Modalities Test (SDMT) Score
Time frame: Baseline, end of treatment (up to 12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30890162Pilloni G, Shaw M, Feinberg C, Clayton A, Palmeri M, Datta A, Charvet LE. Long term at-home treatment with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report. J Neuroeng Rehabil. 2019 Mar 19;16(1):41. doi: 10.1186/s12984-019-0514-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Charvet, MD principal investigator
New York University Medical Center Institutional Review Boards
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS stimulation in people with Multiple Sclerosis and Neurological Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Completing at Least 80% of the Targeted Number of Sessions. (time frame: End of treatment (up to 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.