Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02363296
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2015-02-13
Brief Title:
Main Study Influence on Plasticity of Brain Temperature Sub-Study Phase Triggered Paired Associative Stimulation PAS
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Influence on Plasticity of Brain Temperature
Status:
RECRUITING
Status Verified Date:
2024-08-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sub-Study Phase Triggered Paired Associative Stimulation PAS actively recruiting
Background
-Previous research has shown that the brain s activity changes with changes in brain waves We can study brain activity with a procedure called transcranial magnetic stimulation TMS a form of non-invasive brain stimulation EEG allows for measuring ongoing brain waves The goal of this study is to optimize TMS delivery by utilizing EEG-triggered TMS
Objectives
-To see if changes in brain waves change the brain and body s response to TMS
Eligibility
-Healthy right-handed adults age 18-35
Design
Participants will be screened under another protocol with medical history and physical exam They may take a pregnancy test They will have a magnetic resonance imaging MRI scan of the brain For MRI participants lie on a table that slides in and out of a metal tube that takes pictures with
Participants will have up to 4 outpatient visits lasting 2-3 hours each 4 outpatient visits The following procedures may occur at a visit
Magnetic resonance imaging MRI Participants lie on a table that slides into a machine that takes pictures of the brain
Electroencephalography EEG Small electrodes on the scalp record brain waves
Electromyography EMG Small sticky electrodes on the skin measure muscle activity
Transcranial magnetic stimulation TMS A wire coil is held to the scalp A brief electrical current passes through the coil and affects brain activity
Main Study Influence on Plasticity of Brain Temperature no longer recruiting
Background
- Brain activity changes with changes in body temperature Brain activity can be studied with a procedure called transcranial magnetic stimulation TMS Researchers want to cool the brain through the scalp using a cooling cap They want to see if cooling changes the brain and body s response to TMS
Objectives
- To look at the effects of cooling on the brain
Eligibility
- Right-handed adults age 18-50 who can abstain from caffeine and tobacco
Design
Participants will be screened with medical history and physical exam They will be asked about alcohol use smoking and substance abuse They may take a pregnancy test They may have a magnetic resonance imaging MRI scan of the brain For MRI participants lie on a table that slides in and out of a metal tube that takes pictures
Participants will have 3 outpatient visits The following procedures will occur at each visit
Participants will wear a cooling cap for up to 45 minutes Cool water will flow through the cap It will feel like an ice pack in a towel Their core temperature will be monitored Their temperature will also be measured under their tongue and on scalp stomach forearm and calf
Participants will have TMS before and after wearing the cap A brief electrical current will pass through a wire coil held on their scalp Electrodes that detect muscle movement will be placed on their hand They will also have repetitive TMS which uses repeated magnetic pulses Their wrist will also receive a shock
Background
-Previous research has shown that the brain s activity changes with changes in brain waves We can study brain activity with a procedure called transcranial magnetic stimulation TMS a form of non-invasive brain stimulation EEG allows for measuring ongoing brain waves The goal of this study is to optimize TMS delivery by utilizing EEG-triggered TMS
Objectives
-To see if changes in brain waves change the brain and body s response to TMS
Eligibility
-Healthy right-handed adults age 18-35
Design
Participants will be screened under another protocol with medical history and physical exam They may take a pregnancy test They will have a magnetic resonance imaging MRI scan of the brain For MRI participants lie on a table that slides in and out of a metal tube that takes pictures with
Participants will have up to 4 outpatient visits lasting 2-3 hours each 4 outpatient visits The following procedures may occur at a visit
Magnetic resonance imaging MRI Participants lie on a table that slides into a machine that takes pictures of the brain
Electroencephalography EEG Small electrodes on the scalp record brain waves
Electromyography EMG Small sticky electrodes on the skin measure muscle activity
Transcranial magnetic stimulation TMS A wire coil is held to the scalp A brief electrical current passes through the coil and affects brain activity
Main Study Influence on Plasticity of Brain Temperature no longer recruiting
Background
- Brain activity changes with changes in body temperature Brain activity can be studied with a procedure called transcranial magnetic stimulation TMS Researchers want to cool the brain through the scalp using a cooling cap They want to see if cooling changes the brain and body s response to TMS
Objectives
- To look at the effects of cooling on the brain
Eligibility
- Right-handed adults age 18-50 who can abstain from caffeine and tobacco
Design
Participants will be screened with medical history and physical exam They will be asked about alcohol use smoking and substance abuse They may take a pregnancy test They may have a magnetic resonance imaging MRI scan of the brain For MRI participants lie on a table that slides in and out of a metal tube that takes pictures
Participants will have 3 outpatient visits The following procedures will occur at each visit
Participants will wear a cooling cap for up to 45 minutes Cool water will flow through the cap It will feel like an ice pack in a towel Their core temperature will be monitored Their temperature will also be measured under their tongue and on scalp stomach forearm and calf
Participants will have TMS before and after wearing the cap A brief electrical current will pass through a wire coil held on their scalp Electrodes that detect muscle movement will be placed on their hand They will also have repetitive TMS which uses repeated magnetic pulses Their wrist will also receive a shock
Detailed Description:
1 Objective
The dysregulation of synaptic transmission in certain brain areas may be responsible for some neurological disorders It was demonstrated that synaptic transmission may be modulated through repetitive transcranial magnetic stimulation rTMS and this may be a component of the therapeutic effects of rTMS However rTMS utility is limited due to an inability to focus the stimulation and variability in intervention response Cooling was shown to reduce the neuronal activity in targeted brain areas The goal of this protocol is
to examine the ability of cooling to affect rTMS
Sub-study Phase-triggered paired associative stimulation PAS
Similarly response to transcranial magnetic stimulation TMS is variable However it has been demonstrated that EEG contains information impacting measurable TMS outcomes The goal of this study is to optimize TMS delivery by utilizing EEG phase triggered TMS
2 Study population
We intend to study 18 adult healthy volunteers on an outpatient basis The accrual ceiling requested is 23 subjects to allow for dropouts and screening failures This portion of the study has been completed and recruitment will not continue for the cooling-related
portion of the study
Sub-study Phase-triggered paired associative stimulation PAS
We intend to perform a sub-study to develop a new method of plasticity induction- phase-triggered paired associative stimulation PAS This sub-study requires an additional intended study population of 24 subjects completing the 3 study arms who may be a sub-set of the initially requested 18 subjects from the main study The additional accrual ceiling is 40 subjects to allow for dropouts and screening failures 24 participants complete sub-study40 particpants enrolled in sub-study The total ceiling for the entire protocol is 63
3 Design
Analysis of the data collected during the main study demonstrates the control condition of rPASsham cooling did not result in increased motor evoked potentials MEPs as expected This null effect of the control condition made it difficult to ascertain any effects due to the cooling condition Therefore we propose a new substudy investigating a better form of plasticity induction using EEG phase-triggered TMS
For the completed cooling-related portion of the study we propose using rapid-rate paired associative stimulation rPAS modulated by applying cooling to the scalp to examine the effect of cooling on rTMS Our hypothesis is that cooling the brain will prevent the potentiation normally induced by rPAS We will reduce brain temperature by up to 15 degrees C by applying a cooling helmet to the scalp and then test the effect on potentiation by applying rPAS One of our stopping criterion will be reduction in measured temperature reduction by 2 degrees C
This study consists of one experiment with18 subjects and accrual has been completed The experiment is divided into three session visits each to be carried out at least 1 day apart
The control potentiation in response to rPAS without cooling will be measured during session visit 1 by using the TMS-evoked motor evoked potential MEP In session visit 2 after applying a commercially available liquid cooling helmet for 45 minutes to reduce the temperature of the underlying cerebral cortex by up to 15oC we will then assess the response to rPAS In session visit 3 the MEP will be measured after applying the cooling helmet but with the rPAS procedure substituted with a sham rPAS Session visit 3 is necessary to determine if there are any changes to the MEP in response to cooling alone Thus in the three session visits we will evaluate cooling alone rPAS alone and the two together
Sub-study Phase-triggered paired associative stimulation PAS
The proposed sub-study is to test a methodology to decrease the variability in response to and improve reliability of TMS by utilizing EEG phase-triggered PAS The new method will utilize EEG phase-triggered paired associative stimulation Similarly to the rPAS used in the main study EEG phase-triggered PAS also uses paired median nerve stimulation with TMS to motor cortex However the stimuli are triggered when the EEG recorded from the motor cortex M1 EEGM1 is at a pre-specified phase of the alpha-band 8-12 Hz oscillation
The sub-study to develop the optimal parameters of phase-triggered PAS will consist of upto 4 visits and 3 arms The first visit is a screening and piloting visit the subsequent visits are different arms of the study Two active arms will trigger the paired median nerve and motor cortex TMS according to the phase of the ongoing EEG One arm will trigger the stimuli at the trough of the ongoing EEG phase -90 if the EEG is modeled as a sine wave Another arm will trigger the stimuli at the peak of the ongoing EEG phase 90 A control arm will trigger the paired stimuli at a random delay from the through of the ongoing EEG This control arm serves to deliver paired stimuli at a rate matched to the ongoing EEG but stimulates at a random phase of each alpha oscillation cycle These arms will be pseudo-randomized
Our hypothesis is that stimulating at the through of the ongoing EEG will result in increased plastic changes to the brain as measured through our TMS outcome measures of single pulse MEPs as compared to the control condition of random phase stimulation and stimulation at the peak of the ongoing EEG We also hypothesize that stimulating at the peak of the ongoing EEG will result in a decrease in TMS outcome measures as compared to the control arm and stimulation at the trough of the ongoing EEG This will be a within-subject design of 3 visits for each of the 40 sub-study subjects
4 Outcome measures
The primary outcome measure will be the amplitude of MEPs induced by single TMS pulses
Sub-study Phase-triggered paired associative stimulation PAS
The primary outcome will be pre-post changes in MEP induced by phase-triggered TMS Pre post changes in resting-state EEG rs-EEG will also be analysed Associations between these outcomes and demographics will be included in the analyses
The dysregulation of synaptic transmission in certain brain areas may be responsible for some neurological disorders It was demonstrated that synaptic transmission may be modulated through repetitive transcranial magnetic stimulation rTMS and this may be a component of the therapeutic effects of rTMS However rTMS utility is limited due to an inability to focus the stimulation and variability in intervention response Cooling was shown to reduce the neuronal activity in targeted brain areas The goal of this protocol is
to examine the ability of cooling to affect rTMS
Sub-study Phase-triggered paired associative stimulation PAS
Similarly response to transcranial magnetic stimulation TMS is variable However it has been demonstrated that EEG contains information impacting measurable TMS outcomes The goal of this study is to optimize TMS delivery by utilizing EEG phase triggered TMS
2 Study population
We intend to study 18 adult healthy volunteers on an outpatient basis The accrual ceiling requested is 23 subjects to allow for dropouts and screening failures This portion of the study has been completed and recruitment will not continue for the cooling-related
portion of the study
Sub-study Phase-triggered paired associative stimulation PAS
We intend to perform a sub-study to develop a new method of plasticity induction- phase-triggered paired associative stimulation PAS This sub-study requires an additional intended study population of 24 subjects completing the 3 study arms who may be a sub-set of the initially requested 18 subjects from the main study The additional accrual ceiling is 40 subjects to allow for dropouts and screening failures 24 participants complete sub-study40 particpants enrolled in sub-study The total ceiling for the entire protocol is 63
3 Design
Analysis of the data collected during the main study demonstrates the control condition of rPASsham cooling did not result in increased motor evoked potentials MEPs as expected This null effect of the control condition made it difficult to ascertain any effects due to the cooling condition Therefore we propose a new substudy investigating a better form of plasticity induction using EEG phase-triggered TMS
For the completed cooling-related portion of the study we propose using rapid-rate paired associative stimulation rPAS modulated by applying cooling to the scalp to examine the effect of cooling on rTMS Our hypothesis is that cooling the brain will prevent the potentiation normally induced by rPAS We will reduce brain temperature by up to 15 degrees C by applying a cooling helmet to the scalp and then test the effect on potentiation by applying rPAS One of our stopping criterion will be reduction in measured temperature reduction by 2 degrees C
This study consists of one experiment with18 subjects and accrual has been completed The experiment is divided into three session visits each to be carried out at least 1 day apart
The control potentiation in response to rPAS without cooling will be measured during session visit 1 by using the TMS-evoked motor evoked potential MEP In session visit 2 after applying a commercially available liquid cooling helmet for 45 minutes to reduce the temperature of the underlying cerebral cortex by up to 15oC we will then assess the response to rPAS In session visit 3 the MEP will be measured after applying the cooling helmet but with the rPAS procedure substituted with a sham rPAS Session visit 3 is necessary to determine if there are any changes to the MEP in response to cooling alone Thus in the three session visits we will evaluate cooling alone rPAS alone and the two together
Sub-study Phase-triggered paired associative stimulation PAS
The proposed sub-study is to test a methodology to decrease the variability in response to and improve reliability of TMS by utilizing EEG phase-triggered PAS The new method will utilize EEG phase-triggered paired associative stimulation Similarly to the rPAS used in the main study EEG phase-triggered PAS also uses paired median nerve stimulation with TMS to motor cortex However the stimuli are triggered when the EEG recorded from the motor cortex M1 EEGM1 is at a pre-specified phase of the alpha-band 8-12 Hz oscillation
The sub-study to develop the optimal parameters of phase-triggered PAS will consist of upto 4 visits and 3 arms The first visit is a screening and piloting visit the subsequent visits are different arms of the study Two active arms will trigger the paired median nerve and motor cortex TMS according to the phase of the ongoing EEG One arm will trigger the stimuli at the trough of the ongoing EEG phase -90 if the EEG is modeled as a sine wave Another arm will trigger the stimuli at the peak of the ongoing EEG phase 90 A control arm will trigger the paired stimuli at a random delay from the through of the ongoing EEG This control arm serves to deliver paired stimuli at a rate matched to the ongoing EEG but stimulates at a random phase of each alpha oscillation cycle These arms will be pseudo-randomized
Our hypothesis is that stimulating at the through of the ongoing EEG will result in increased plastic changes to the brain as measured through our TMS outcome measures of single pulse MEPs as compared to the control condition of random phase stimulation and stimulation at the peak of the ongoing EEG We also hypothesize that stimulating at the peak of the ongoing EEG will result in a decrease in TMS outcome measures as compared to the control arm and stimulation at the trough of the ongoing EEG This will be a within-subject design of 3 visits for each of the 40 sub-study subjects
4 Outcome measures
The primary outcome measure will be the amplitude of MEPs induced by single TMS pulses
Sub-study Phase-triggered paired associative stimulation PAS
The primary outcome will be pre-post changes in MEP induced by phase-triggered TMS Pre post changes in resting-state EEG rs-EEG will also be analysed Associations between these outcomes and demographics will be included in the analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-M-0066 | None | None | None |