Understand the Effects of tACS on the BrainNCT05503823
Investigating Transcranial Alternating Current Stimulation (tACS) Preconditioning Effects on Resting and Active Motor Threshold
A study testing tACS or tRNS and TMS in people with Understand the Effects of tACS on the Brain, run by University of Manitoba at 1 site in Canada.
Trial summary
Previous studies have looked at the potential of using transcranial direct current stimulation (tDCS) to prime the brain in order to lower the resting motor threshold. The resting motor threshold (RMT) is the intensity at which repeated transcranial magnetic stimulation (rTMS) is applied for treatments. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Understand the Effects of tACS on the Brain
- What is being tested?
- tACS or tRNS and TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2022to 1 Jul 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment score greater than or equal to 26
Who cannot join
- being pregnant
- having any metallic implants in the head or upper body
- having a pacemaker
- having a history of seizures
- having a diagnosed major psychotic disorder
- having any nervous system medication (depression, anxiety, sleep, pain, etc.) on a daily basis
- having a brain injury
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have looked at the potential of using transcranial direct current stimulation (tDCS) to prime the brain in order to lower the resting motor threshold. The resting motor threshold (RMT) is the intensity at which repeated transcranial magnetic stimulation (rTMS) is applied for treatments. The RMT is the lowest intensity at which the participant's muscle responds with the motor evoked potential peak-to-peak amplitude greater than 50μV for 5 of 10 trials when the hand is relaxed. The active motor threshold (AMT) is the lowest intensity that produces MEP with peak-to-peak amplitude greater than 100 μV for 5 of 10 trials while the participant maintains 10-30% of maximal voluntary contraction. The RMT and AMT is different for each person and the high intensity TMS pulses can be difficult for some of the patients in the current Alzheimer's rTMS treatment study to tolerate. Therefore, if the treatment can still be applied with lower intensities, it would be more tolerable for some people. The limited research on both tDCS and transcranial alternating current stimulation (tACS) in priming the brain for TMS are not enough to determine if they are effective in priming the brain. The studies that include tDCS have small sample size and inconclusive results. The studies with tACS are using very high frequencies of 140 Hz to 250 Hz. The objective of this research study is to determine if priming the brain with tACS at 40 Hz or tRNS for 10 minutes is able to reduce the resting and active motor threshold. Therefore, for people with higher RMT and AMT, priming with tACS or tRNS could be used to lower intensities while stimulating the brain for treatments.
Read the detailed description
When volunteers are interested in participating in the study and they contact the PI or RA, the PI or RA will briefly explain the study. If the participant is still interested in participating, two 2-hour time slot will be scheduled for the participant to visit the lab. At the scheduled first visit, the PI or RA will provide and explain each part of the consent from. Once the participant is ready to participate, they will be asked to sign the consent form and will be provided a copy of the signed consent form. The PI or RA will assign a code to each participant. The code will be in the form of XY-RMT_##, where XY are the first letters of the first and last names and ## is a two digit number. After the consent form is signed, it will be placed in a locked cabinet located in our supervisor's office at Riverview Health Center.
Once the participant is fully enrolled, the RA and PI conduct the Montreal Cognitive Assessment (MoCA) and the Questionnaire to determine if the participant meets the inclusion criteria. If the participants have no health or physical conflicts with the application of electrical and magnetic stimulation and have a MoCA score higher than 26 out of 30, the PI and RA will set up the participant and the devices. Using our neuronavigation system in the TMS lab (at Riverview Health Center), a tracking headband will be placed on the participant and a tracker is used to measure the scalp and determine anatomical positions. Electrodes will also be placed on the participants first dorsal interosseous (FDI) muscle of the participant's right hand to record the electromyography (EMG).
The TMS device is the Magstim Rapid 2 Stimulator on single pulse setting with the figure-of-eight coil AirFilm Coil. The EMG device is the EMG Recording Pod from Brainsight 2. The tACS device is the Soterix Medical Inc. tES (transcranial electrical stimulation) (Model: 2001).
For the resting motor threshold (RMT), the PI exposes the participant's C3 section of the brain (area of the left hemisphere of the brain in 10 20 model which is related to the hand area of the primary motor cortex) to single pulses of TMS starting at 50% intensity of the maximum intensity available. This is done while the right hand is at a resting (relax) position. The RA will increase the intensity by increments of 5% until a visible twitch in the right hand is observed. Then the intensity will be decreased by decrements of 1% until 10 consistent visible twitches are observed in arrow. The minimum intensity is recorded as the RMT and the exact position and direction of the coil relative to the headband will be recorded as the target "hotspot" via the neuronavigational system (Vicra position sensor camera). The 10 consecutive successful EMGs will be recorded as the pre-priming data of the resting muscle. A similar procedure will be followed for the active motor threshold (AMT) with the only difference being the condition of the right hand. For an active recording, the participant will be asked to gently grab the arm rest of the chair so the muscle is activated 10-30% of maximal voluntary contraction and the 10 pulses will be exposed to the "hotspot as located by the Vicra camera.
To prime the brain using the tACS, the participant will be given a 5-minute break during which the RA places the active electrode of tACS on the marked "hotspot" and the reference on the contralateral supraorbital area of the head (right side of the forehead above the eyebrow). After the break, the stimulation begins at a frequency of 40 Hz and current intensity of 0.75 mA amplitude for duration of 10 minutes. Immediately after the stimulation the EMG will be recorded through 10 TMS pulses on active FDI muscle and 10 pulses with resting FDI muscle. The same procedure will be followed once 30 minutes after tACS stimulation and once after 1 hour. Similar procedure will be done for the right side RMT/AMT measurement which moves the left hand.
Overall, there will be 40 resting EMG recordings and 40 active EMG recording for each participant. The resting EMG recording will be compared at each time interval for any observable difference in average motor evoked potential (MEP) and the active EMG recordings are compared for difference in both the silence period which appears after the involuntary twitch and the MEP.
The same process will be done for a second time either 4 hours after the first session or on a different day. The only difference being that the participant receives 10 minutes of tRNS instead of tACS.
- Being tested
- tACS or tRNS and TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS or tRNS and TMSDevice
A light electrical current will be applied to the scalp of the participants via 2 electrodes. The resting and active motor threshold will be measured before, right after, after 30 minutes, and after 1 hour of receiving the tACS or tRNS.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Each participant will have their resting and active motor threshold measured using the transcranial magnetic stimulation (TMS) device. Participants will receive tACS for 10 minutes in the first session and tRNS in the second session. Receives: Device: tACS or tRNS and TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Motor Threshold
The peak-to-peak amplitude of the muscle signal from the resting motor threshold.
Measured: Before tACS, right after tACS, 30 minutes after tACS, and 1 hour after tACS
Secondary outcomes (1)
Active Motor Threshold
Cortical silent period measured post-MEP.
Measured: Before tACS, right after tACS, 30 minutes after tACS, and 1 hour after tACS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start16 Sep 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: Preliminary results indicate no significant difference in RMT pre- and post-tACS.
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.
- Other trials for Understand the Effects of tACS on the BrainStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same stimulations to analyze the effects of tACS on the brain.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503823
- Sponsor's protocol ID
- HS25595 (B2022:070
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 6 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Transcranial Alternating Current Stimulation (tACS) Preconditioning Effects on Resting and Active Motor Threshold
- ClinicalTrials.gov ID
- NCT05503823
- Acronym / sponsor ID
- HS25595 (B2022:070
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary results indicate no significant difference in RMT pre- and post-tACS.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Posted 6 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have looked at the potential of using transcranial direct current stimulation (tDCS) to prime the brain in order to lower the resting motor threshold. The resting motor threshold (RMT) is the intensity at which repeated transcranial magnetic stimulation (rTMS) is applied for treatments. The RMT is the lowest intensity at which the participant's muscle responds with the motor evoked potential peak-to-peak amplitude greater than 50μV for 5 of 10 trials when the hand is relaxed. The active motor threshold (AMT) is the lowest intensity that produces MEP with peak-to-peak amplitude greater than 100 μV for 5 of 10 trials while the participant maintains 10-30% of maximal voluntary contraction. The RMT and AMT is different for each person and the high intensity TMS pulses can be difficult for some of the patients in the current Alzheimer's rTMS treatment study to tolerate. Therefore, if the treatment can still be applied with lower intensities, it would be more tolerable for some people. The limited research on both tDCS and transcranial alternating current stimulation (tACS) in priming the brain for TMS are not enough to determine if they are effective in priming the brain. The studies that include tDCS have small sample size and inconclusive results. The studies with tACS are using very high frequencies of 140 Hz to 250 Hz. The objective of this research study is to determine if priming the brain with tACS at 40 Hz or tRNS for 10 minutes is able to reduce the resting and active motor threshold. Therefore, for people with higher RMT and AMT, priming with tACS or tRNS could be used to lower intensities while stimulating the brain for treatments.
Detailed description
When volunteers are interested in participating in the study and they contact the PI or RA, the PI or RA will briefly explain the study. If the participant is still interested in participating, two 2-hour time slot will be scheduled for the participant to visit the lab. At the scheduled first visit, the PI or RA will provide and explain each part of the consent from. Once the participant is ready to participate, they will be asked to sign the consent form and will be provided a copy of the signed consent form. The PI or RA will assign a code to each participant. The code will be in the form of XY-RMT_##, where XY are the first letters of the first and last names and ## is a two digit number. After the consent form is signed, it will be placed in a locked cabinet located in our supervisor's office at Riverview Health Center.
Once the participant is fully enrolled, the RA and PI conduct the Montreal Cognitive Assessment (MoCA) and the Questionnaire to determine if the participant meets the inclusion criteria. If the participants have no health or physical conflicts with the application of electrical and magnetic stimulation and have a MoCA score higher than 26 out of 30, the PI and RA will set up the participant and the devices. Using our neuronavigation system in the TMS lab (at Riverview Health Center), a tracking headband will be placed on the participant and a tracker is used to measure the scalp and determine anatomical positions. Electrodes will also be placed on the participants first dorsal interosseous (FDI) muscle of the participant's right hand to record the electromyography (EMG).
The TMS device is the Magstim Rapid 2 Stimulator on single pulse setting with the figure-of-eight coil AirFilm Coil. The EMG device is the EMG Recording Pod from Brainsight 2. The tACS device is the Soterix Medical Inc. tES (transcranial electrical stimulation) (Model: 2001).
For the resting motor threshold (RMT), the PI exposes the participant's C3 section of the brain (area of the left hemisphere of the brain in 10 20 model which is related to the hand area of the primary motor cortex) to single pulses of TMS starting at 50% intensity of the maximum intensity available. This is done while the right hand is at a resting (relax) position. The RA will increase the intensity by increments of 5% until a visible twitch in the right hand is observed. Then the intensity will be decreased by decrements of 1% until 10 consistent visible twitches are observed in arrow. The minimum intensity is recorded as the RMT and the exact position and direction of the coil relative to the headband will be recorded as the target "hotspot" via the neuronavigational system (Vicra position sensor camera). The 10 consecutive successful EMGs will be recorded as the pre-priming data of the resting muscle. A similar procedure will be followed for the active motor threshold (AMT) with the only difference being the condition of the right hand. For an active recording, the participant will be asked to gently grab the arm rest of the chair so the muscle is activated 10-30% of maximal voluntary contraction and the 10 pulses will be exposed to the "hotspot as located by the Vicra camera.
To prime the brain using the tACS, the participant will be given a 5-minute break during which the RA places the active electrode of tACS on the marked "hotspot" and the reference on the contralateral supraorbital area of the head (right side of the forehead above the eyebrow). After the break, the stimulation begins at a frequency of 40 Hz and current intensity of 0.75 mA amplitude for duration of 10 minutes. Immediately after the stimulation the EMG will be recorded through 10 TMS pulses on active FDI muscle and 10 pulses with resting FDI muscle. The same procedure will be followed once 30 minutes after tACS stimulation and once after 1 hour. Similar procedure will be done for the right side RMT/AMT measurement which moves the left hand.
Overall, there will be 40 resting EMG recordings and 40 active EMG recording for each participant. The resting EMG recording will be compared at each time interval for any observable difference in average motor evoked potential (MEP) and the active EMG recordings are compared for difference in both the silence period which appears after the involuntary twitch and the MEP.
The same process will be done for a second time either 4 hours after the first session or on a different day. The only difference being that the participant receives 10 minutes of tRNS instead of tACS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same stimulations to analyze the effects of tACS on the brain.
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: tACS or tRNS and TMSEach participant will have their resting and active motor threshold measured using the transcranial magnetic stimulation (TMS) device. Participants will receive tACS for 10 minutes in the first session and tRNS in the second session. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Montreal Cognitive Assessment score greater than or equal to 26
Key exclusion criteria (7 listed)
- being pregnant
- having any metallic implants in the head or upper body
- having a pacemaker
- having a history of seizures
- having a diagnosed major psychotic disorder
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 |
|---|---|---|
| tACS or tRNS and TMSA light electrical current will be applied to the scalp of the participants via 2 electrodes. The resting and active motor threshold will be measured before, right after, after 30 minutes, and after 1 hour of receiving the tACS or tRNS. | Device | Participants |
Primary outcome
Resting Motor Threshold
Time frame: Before tACS, right after tACS, 30 minutes after tACS, and 1 hour after tACS
The peak-to-peak amplitude of the muscle signal from the resting motor threshold.
1 secondary outcome
Active Motor Threshold
Time frame: Before tACS, right after tACS, 30 minutes after tACS, and 1 hour after tACS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS or tRNS and TMS in people with Understand the Effects of tACS on the Brain, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 7 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 6 Oct 2023. 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 Canada. 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 6 Oct 2023). 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?
Resting Motor Threshold (time frame: Before tACS, right after tACS, 30 minutes after tACS, and 1 hour after tACS). 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 6 Oct 2023.