Home-Based Brain Stimulation for Post-COVID Syndrome

Overseen By Allyson Smith, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Epilepsy, Metallic implants, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with brain fog and concentration issues following COVID-19, known as post-COVID syndrome. It employs a safe, noninvasive technique called transcranial direct current stimulation (tDCS), which uses mild electrical currents applied to the brain through a home-use device. Participants will receive either the actual treatment or a sham version for comparison. Individuals who continue to experience symptoms like confusion or difficulty concentrating after recovering from COVID-19 may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for post-COVID symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this home-based tDCS method is safe for post-COVID syndrome patients?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. tDCS uses a gentle electrical current to stimulate the brain, and studies have found it to have a good safety record. Most side effects are mild and temporary, such as slight tingling on the scalp where the electrodes are placed.

In various studies, tDCS has been used on individuals with neurological disorders, showing similar safety results. So far, no serious problems have been reported, suggesting that tDCS is well-tolerated by patients.

Overall, current evidence supports tDCS as a safe option for those considering joining a clinical trial. However, as with any medical treatment, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for post-COVID syndrome that often focus on medications or physical therapy, transcranial Direct Current Stimulation (tDCS) offers a unique, non-invasive approach. This technique delivers a gentle electrical current to the left dorsolateral prefrontal cortex, potentially enhancing brain function without the need for drugs. Researchers are excited because tDCS can be administered at home with remote supervision, providing a convenient and accessible option for patients. This innovative method could offer relief in a more flexible, patient-friendly manner, expanding the possibilities for managing post-COVID symptoms.

What evidence suggests that home-based tDCS is effective for post-COVID syndrome?

Research has shown that transcranial direct current stimulation (tDCS) might improve well-being in individuals who have had COVID-19. In this trial, participants will join either an active tDCS group or a sham tDCS group. Studies have found that tDCS, when applied to a brain area involved in planning and decision-making, can reduce physical fatigue. This offers hope for those with post-COVID syndrome, as fatigue is a common issue. Additionally, tDCS has been associated with reduced anxiety and improved overall quality of life. Importantly, it appears safe, with only minor side effects reported in studies. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have had COVID-19 and are now experiencing persistent symptoms like 'brain fog', confusion, memory issues, concentration problems, or delirium. Candidates must be able to consent and not have a major neurological condition before COVID-19, metal implants in the head/neck area, brain stimulators, epilepsy history, pacemakers, active substance dependence (except tobacco), ADHD or severe mental illness.

Inclusion Criteria

I have long-term symptoms from COVID-19, like 'brain fog' and memory issues.

Ability to provide informed consent

Exclusion Criteria

Pregnancy

You had a serious neurological illness before joining the study.

I have metal implants in my head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily active or sham tDCS stimulation for 4 weeks through a home-based device in remotely-supervised 30-min sessions

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests if home-based transcranial direct current stimulation (tDCS) can improve cognitive functions such as attention and processing speed in patients with post-COVID conditions. Participants will receive either an active tDCS treatment or a sham (placebo-like) version to compare effects.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.

Group II: Sham tDCS Placebo Group 1 Intervention

This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a study of 70 patients with post-acute sequelae of SARS-CoV-2 infection (PASC), High-Definition transcranial Direct Current Stimulation (HD-tDCS) significantly reduced fatigue compared to a sham treatment, with a mean reduction of 22.11 points on the Modified Fatigue Impact Scale (MFIS).

The active HD-tDCS treatment also led to significant improvements in anxiety levels and quality of life, while showing no notable effect on pain, indicating its potential as a therapeutic option for managing PASC-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for fatigue in post-acute sequelae of SARS-CoV-2 (PASC). Santana, K., França, E., Sato, J., et al.[2023]

Transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex significantly reduced physical fatigue in patients with post-COVID syndrome after eight sessions, with effects lasting up to one month.

The treatment also led to improvements in depressive symptoms, while no significant changes were observed in cognitive fatigue or quality of life, and all reported side effects were mild and transient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for post-COVID fatigue: a randomized, double-blind, controlled pilot study. Oliver-Mas, S., Delgado-Alonso, C., Delgado-Álvarez, A., et al.[2023]

Transcranial direct current stimulation (tDCS) is a promising noninvasive treatment that can improve symptoms of various nervous system conditions, and its effects are enhanced with daily use, making at-home application an attractive option.

The study provides comprehensive guidelines for safely and effectively using tDCS at home, which can improve patient access and compliance, especially for those with mobility challenges or living in remote areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. Charvet, LE., Shaw, MT., Bikson, M., et al.[2020]

This study will investigate the safety and efficacy of combining transcranial direct current stimulation (tDCS) with conventional rehabilitation in 80 patients with disorders of consciousness (DOC) after traumatic brain injury (TBI) over a 4-week period.

The trial aims to provide advanced evidence for tDCS as a non-invasive treatment option to promote early awakening in DOC patients, addressing a significant gap in large-sample clinical trials for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial. Li, S., Dong, X., Sun, W., et al.[2020]

Transcranial Direct Current Stimulation (tDCS) is a promising non-pharmacological treatment that may help improve physical functions and reduce symptoms like muscular pain and fatigue in COVID-19 survivors.

tDCS could enhance neuroplasticity and support central nervous system recovery, making it a valuable addition to existing pharmacological treatments for patients experiencing long-term effects of COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation as a strategy to manage COVID-19 pain and fatigue. Silva Filho, E., Moura, S., Santos, ADC., et al.[2021]

A home-based protocol for transcranial direct current stimulation (tDCS) called remotely supervised (RS)-tDCS was found to be tolerable for participants, with no serious adverse events reported across 6779 sessions in six clinical trials involving 308 participants.

Common mild side effects included tingling, itching, and warmth at the electrode site, but these were similar in both active and sham tDCS conditions, indicating that RS-tDCS is feasible for use in clinical trials without significant discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions. Pilloni, G., Vogel-Eyny, A., Lustberg, M., et al.[2022]

Transcranial direct current stimulation (tDCS) was found to be feasible and safe for use in outpatient therapy for stroke patients, with 100% adherence among the 7 participants who completed the study over 5-6 weeks.

Most participants (71%) reported positive impressions of tDCS, experiencing acute improvements in function and energy, with only one adverse event unrelated to the treatment and mild side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Cleland, BT., Galick, M., Huckstep, A., et al.[2020]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

A study involving 64 participants with bipolar disorder assessed the efficacy and safety of home-based transcranial direct current stimulation (tDCS) over 6 weeks, but found no significant improvement in depression scores compared to a sham treatment.

While tDCS did not show efficacy in reducing depression symptoms, it was deemed safe and tolerable, with some participants reporting higher pain scores associated with the active treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of daily home-based transcranial direct current stimulation as adjunct treatment for bipolar depressive episodes: Double-blind sham-controlled randomized clinical trial. Lee, J., Lee, CW., Jang, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10116605/

Transcranial direct current stimulation for post-COVID fatigue In conclusion, our results suggest that transcranial direct current stimulation on the dorsolateral prefrontal cortex may improve physical fatigue. Further ...

2. nature.com nature.com/articles/s41598-024-52763-4

Transcranial direct current stimulation (tDCS) in the ... Secondary outcome measures were a change in the FIS at follow-up and changes in A-PASC (post-covid symptoms), GAD-7 (anxiety symptoms), PHQ-9 ( ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04876417

Transcranial Direct Current Stimulation (tDCS) for Post ... Our central hypothesis is that tDCS will improve fatigue short- and long-term, and thus will improve quality of life (QOL) in recovered COVID-19 patients and ...

4. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(25)00064-6/fulltext

Evaluating the efficacy of repetitive anodal transcranial ... During the four stimulation sessions, participants experienced minimal side effects, and no significant adverse events were reported (Fig. 1B).

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25003110

A randomized, double-blind, sham-controlled trial Participants aged18–75 with confirmed COVID-19 diagnosis in the past six months were eligible if they had mild–moderate COVID-19 symptoms and persistent and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05753202

Study Details | NCT05753202 | tDCS in Post-COVID ... Patients will receive 15 neuromodulation sessions through transcranial electrical stimulation for 3 weeks, associated with cognitive stimulation during therapy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9093082/

Efficacy and safety of HD-tDCS and respiratory ... Efficacy and safety of HD-tDCS and respiratory rehabilitation for critically ill patients with COVID-19 The HD-RECOVERY randomized clinical trial