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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.

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 data supports the effectiveness of the treatment tDCS for post-COVID syndrome?

Research shows that transcranial direct current stimulation (tDCS) can help reduce physical fatigue in people with post-COVID syndrome. In a study, patients who received tDCS reported significant improvements in physical fatigue compared to those who did not receive the active treatment. ^{1 2 3 4 5}

Is home-based transcranial direct current stimulation (tDCS) safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans when used at an intensity of 4 mA or less for up to 60 minutes per day. Mild side effects like tingling, itching, and fatigue have been reported, but no severe complications have been observed. ^{6 7 8 9 10}

How is the treatment tDCS unique for post-COVID syndrome?

Transcranial Direct Current Stimulation (tDCS) is unique for post-COVID syndrome because it is a non-invasive treatment that can be administered at home, targeting the brain to improve symptoms like fatigue and depressive symptoms. Unlike other treatments, tDCS involves applying a mild electrical current to specific brain areas, and its effects are cumulative with daily use, making it a novel approach for managing post-COVID symptoms. ^{1 2 3 4 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for fatigue in post-acute sequelae of SARS-CoV-2 (PASC). [2023]

2. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for post-COVID fatigue: a randomized, double-blind, controlled pilot study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. [2020]

4. England 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. [2020]

5. Brazil pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation as a strategy to manage COVID-19 pain and fatigue. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

9. Switzerland 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. [2022]

10. United States 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. [2022]