Transcranial Direct Current StimulationNCT06241963
High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy
A study testing Active Comparator: Unilateral real High definition transcranial direct current stimulation and Active Comparator: Bilateral real High definition transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and EEG, run by Anhui Medical University at 1 site in China.
Trial summary
To observe the clinical effect and safety of transcranial electrical stimulation on patients with refractory epilepsy before and after treatment and analyze its therapeutic mechanism. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, EEG, Functional Magnetic Resonance Imaging
- What is being tested?
- Active Comparator: Unilateral real High definition transcranial direct current stimulation and Active Comparator: Bilateral real High definition transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of refractory epilepsy
- Right-handed and aged 18-50 years old and primary school education or above;
- No major neurological or mental illness, no head injury, alcohol dependence or drug dependence;
- During the experiment, the subjects did not smoke, drink, get sick and take psychotropic drugs, and there were no major life events that caused mood changes.
Who cannot join
- organic brain injury, neurological diseases or serious physical diseases;
- Have a history of substance abuse and drug dependence, or have used antipsychotic drugs in the past three months, and have serious suicidal tendencies;
- There are contraindications for MRI or EEG or transcranial magnetic stimulation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui
Kai Wang, PhD, +86-0551-62923704, wangkai1964@126.com
Xingui Chen, PhD, +8615955161468, chen_xin_gui@126.com
About this study
Official title: The Efficacy, Safety and Mechanism of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in the Treatment of Refractory Epilepsy
To observe the clinical effect and safety of transcranial electrical stimulation on patients with refractory epilepsy before and after treatment and analyze its therapeutic mechanism.
Read the detailed description
All participants underwent a medical evaluation that included physical examination and routine laboratory studies before and after high definition transcranial direct current stimulation (HD-tDCS) treatment.Upon meeting the inclusion criteria and providing informed consent, each participant will complete clinical assessments by a trained investigator and HD-tDCS treatment at Anhui mental health centre.
At least 90 participants were randomized (1:1:1) to receive "bilateral active" ,"Unilateral active" or "Sham" treatment protocol. The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays.Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Before and after the tDCS treatment, the patients had receiving a battery measure of neuropsychological tests, Magnetic resonance imaging scan in multimodalities, VEEG and Resting motor threshold.
The clinical symptom of participants were followed 4 weeks and 12 weeks after the last treatment.
- Conditions
- Transcranial Direct Current Stimulation, EEG, Functional Magnetic Resonance Imaging, Refractory Epilepsy, Transcranial Magnetic Stimulation
- Being tested
- Active Comparator: Unilateral real High definition transcranial direct current stimulation, Active Comparator: Bilateral real High definition transcranial direct current stimulation, Sham Comparator: Sham High definition transcranial direct current stimulation
- Keywords
- Refractory Epilepsy, Functional Magnetic Resonance Imaging, EEG, Transcranial magnetic stimulation
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Unilateral real High definition transcranial direct current stimulationDevice
Improvement of cortical excitability, unilateral stimulation was effective, and no side effects were observed
Active Comparator: Bilateral real High definition transcranial direct current stimulationDevice
Improved cortical excitability, the effect was more obvious than unilateral stimulation, the effect lasted longer, and no side effects were observed
Sham Comparator: Sham High definition transcranial direct current stimulationDevice
The sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors
| Study group | Role | What they receive |
|---|---|---|
| Unilateral real High definition transcranial direct current stimulation | Active comparator | The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays. Receives: Device: Active Comparator: Unilateral real High definition transcranial direct current stimulation |
| Bilateral real High definition transcranial direct current stimulation | Active comparator | The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart.. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. Receives: Device: Active Comparator: Bilateral real High definition transcranial direct current stimulation |
| Sham High definition transcranial direct current stimulation | Sham comparator | The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10.
The 30 subjects were randomly divided into two groups, 15 receiving bilateral Sham HD-tDCS and 15 receiving unilateral Sham HD-tDCS.
Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. Receives: Device: Sham Comparator: Sham High definition transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of Epilepsy diary
The reduction of seizure frequency in patients with epilepsy will constitute the primary outcome measure to evaluate the efficacy of HD-tDCS, reflecting the improvement of patients' clinical symptoms. Patients and family members are asked to keep an epilepsy diary to record the time, duration, and status of the seizure.
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
Secondary outcomes (12)
The changes of VEEG
The number of discharges recorded by VEEG before and after the intervention, as well as the decrease in epileptiform discharge index, were used as indicators to evaluate the improvement of epilepsy symptoms
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of resting-state functional connectivity
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI and resting-state EEG.
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of resting motor threshold(RMT）
Previous studies have found that the resting movement threshold is an effective measure of cortical excitability in epilepsy patients, and can better predict the therapeutic effect. An elevated resting movement threshold indicates that the treatment is responding.
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of glutamate receptor-mediated intracortical facilitation (ICF)
ICF is a 120% RMT stimulation administered 15 ms after 90% RMT intensity stimulation, glutamate receptor-mediated intracortical promotion
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of GABA-A receptor-mediated short septal cortical inhibition (SICI)
SICI is 120% RMT administered 4 ms after 80% RMT intensity stimulation in response to GABA-A receptor-mediated short-interval cortical inhibition
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of GABA-B receptor-mediated long septal cortical inhibition (LICI).
LICI is 120% RMT administered 150ms after 120% RMT intensity stimulation in response to GABA-A receptor-mediated long-interval cortical inhibition,
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of MoCA Score
MoCA was developed by Nasreddine et al. based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. We adopted a localized version (Mandarin version，includes 2 alternative versions) in line with the Chinese cultural background.A higher score indicates improvement
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Hamilton Depression Rating Scale (HAMD) Score
The HAMD is a clinic ian-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Hamilton Anxiety Scale (HAMA) Score
The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Chinese auditory learning test Score
A group consists of 15 words, read to the subject at a speed of one per second, after reading, let the patient repeat these 15 words, record the number of words spoken correctly, repeat the above behavior five times, start the timer after the end, let the patient recall 15 words after 30 minutes, and calculate the correct number，The more vocabulary is memorized, the better the score
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of TMT (Trail Making Test) Score
The Trail Making Test (TMT) is divided into two parts, part A and part B. Part A requires the subject to connect 25 Numbers on the paper in sequence, and part B requires the subject to connect 25 Numbers of different colors alternately in sequence. The time it takes for the subject to complete all the Numbers is the subject's final score.the shorter the better.
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Face associative memory Score
The associative memory was estimated using a face-cued word association test. In the face-cued word association test, participants studied 20 human face photographs presented individually in grayscale on a computer screen for 4 s per face. Each photograph displayed a unique common word that the participants read aloud as each face-word pair was shown. The participants were instructed to memorize the word associated with each face. After the face-word pairs were presented, participants were shown the same 20 faces, individually and in a different and randomized order. They were asked to recall the words that were presented with each face. Each face was scored as correct or incorrect. These processes are carried out 2 times in total. The average number of successful answers was defined as the associative memory score.The more faces you remember correctly, the higher your score.
Measured: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start12 Feb 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241963
- Sponsor's protocol ID
- AHMU-tDCS-epilepsy
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Mechanism of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in the Treatment of Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT06241963
- Acronym / sponsor ID
- AHMU-tDCS-epilepsy
- Conditions
- Transcranial Direct Current Stimulation, EEG, Functional Magnetic Resonance Imaging, Refractory Epilepsy, Transcranial Magnetic Stimulation
- Keywords
- Refractory Epilepsy, Functional Magnetic Resonance Imaging, EEG, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe the clinical effect and safety of transcranial electrical stimulation on patients with refractory epilepsy before and after treatment and analyze its therapeutic mechanism.
Detailed description
All participants underwent a medical evaluation that included physical examination and routine laboratory studies before and after high definition transcranial direct current stimulation (HD-tDCS) treatment.Upon meeting the inclusion criteria and providing informed consent, each participant will complete clinical assessments by a trained investigator and HD-tDCS treatment at Anhui mental health centre.
At least 90 participants were randomized (1:1:1) to receive "bilateral active" ,"Unilateral active" or "Sham" treatment protocol. The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .
In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays.Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Before and after the tDCS treatment, the patients had receiving a battery measure of neuropsychological tests, Magnetic resonance imaging scan in multimodalities, VEEG and Resting motor threshold.
The clinical symptom of participants were followed 4 weeks and 12 weeks after the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral real High definition transcranial direct current stimulation | Active comparator | Device: Active Comparator: Unilateral real High definition transcranial direct current stimulationThe left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 . In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays. |
| Bilateral real High definition transcranial direct current stimulation | Active comparator | Device: Active Comparator: Bilateral real High definition transcranial direct current stimulationThe left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 . In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart.. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. |
| Sham High definition transcranial direct current stimulation | Sham comparator | Device: Sham Comparator: Sham High definition transcranial direct current stimulationThe left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10. The 30 subjects were randomly divided into two groups, 15 receiving bilateral Sham HD-tDCS and 15 receiving unilateral Sham HD-tDCS. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of refractory epilepsy
- Right-handed and aged 18-50 years old and primary school education or above;
- No major neurological or mental illness, no head injury, alcohol dependence or drug dependence;
- During the experiment, the subjects did not smoke, drink, get sick and take psychotropic drugs, and there were no major life events that caused mood changes.
Key exclusion criteria (3 listed)
- organic brain injury, neurological diseases or serious physical diseases;
- Have a history of substance abuse and drug dependence, or have used antipsychotic drugs in the past three months, and have serious suicidal tendencies;
- There are contraindications for MRI or EEG or transcranial magnetic stimulation.
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 |
|---|---|---|
| Active Comparator: Unilateral real High definition transcranial direct current stimulationImprovement of cortical excitability, unilateral stimulation was effective, and no side effects were observed | Device | Unilateral real High definition transcranial direct current stimulation |
| Active Comparator: Bilateral real High definition transcranial direct current stimulationImproved cortical excitability, the effect was more obvious than unilateral stimulation, the effect lasted longer, and no side effects were observed | Device | Bilateral real High definition transcranial direct current stimulation |
| Sham Comparator: Sham High definition transcranial direct current stimulationThe sham stimulation is mainly used for blank control, control variables, and exclude the interference of other factors | Device | Sham High definition transcranial direct current stimulation |
Primary outcome
The changes of Epilepsy diary
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The reduction of seizure frequency in patients with epilepsy will constitute the primary outcome measure to evaluate the efficacy of HD-tDCS, reflecting the improvement of patients' clinical symptoms. Patients and family members are asked to keep an epilepsy diary to record the time, duration, and status of the seizure.
12 secondary outcomes
The changes of VEEG
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of resting-state functional connectivity
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of resting motor threshold(RMT）
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of glutamate receptor-mediated intracortical facilitation (ICF)
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of GABA-A receptor-mediated short septal cortical inhibition (SICI)
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of GABA-B receptor-mediated long septal cortical inhibition (LICI).
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of MoCA Score
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Hamilton Depression Rating Scale (HAMD) Score
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Hamilton Anxiety Scale (HAMA) Score
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Chinese auditory learning test Score
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of TMT (Trail Making Test) Score
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
The changes of Face associative memory Score
Time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Unilateral real High definition transcranial direct current stimulation and Active Comparator: Bilateral real High definition transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and EEG, run by Anhui Medical University at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (+86-0551-62923704, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of Epilepsy diary (time frame: Baseline and 10 workdays post-treatment,and follow-up to 1 months and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.