- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07593859
Overcoming the Barriers to Effective Transcranial Temporal Interference Stimulation in Humans
연구 개요
상세 설명
Remedies for treatment resistance in psychiatric and neurological disorders is a great unmet need. Invasive neuromodulation, such as deep brain stimulation (DBS), applied to a targeted brain region is one option that has helped regulate or modify, abnormal electrical patterns in many patients with neurological deficits; However, invasive approaches carry significant risks while having limited targeting flexibility. Transcranial temporal interference stimulation (TIS) is a non-invasive neuromodulation method with much more favorable focus in deep brain targets than traditional forms of transcranial alternating current stimulation (tACS). tTIS achieves its focal effect by delivering two sinusoidal currents, that are both high in frequency, but that are slightly different from one another (e.g. 1000 kHz and 1020 kHz) through electrodes placed on the scalp. Frequencies that are in the kilohertz range alone do not elicit neuronal response, however the interaction of the two high-frequency currents creates an electric field with a high-frequency carrier (fc, e.g. 1010 kHZ) that is modulated by a low-frequency beat (fb, e.g. 20 Hz). If fc is high enough (>1 kHz) and fb low enough (<100 Hz), neurons respond much more strongly to fb than fc.
Safety and tolerability of TIS has recently been demonstrated in humans with findings indicating that TIS poses no greater risk than other common non-invasive techniques for transcranial current stimulation (TCS). The spatial distribution of the beat field (Eb) is distinct from other noninvasive stimulation methods in three ways: 1) it is focal, 2) it can peak deep in the brain, 3) it can be steered through the brain without moving the electrodes. These features have been demonstrated in mouse experiments, and in human simulation studies.
In humans, motor-evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) applied to the motor cortex provide an established assay of corticospinal excitability. TMS experiments have provided direct evidence that phase-dependent neuromodulation can be induced by transcranial alternating current stimulation (tACS), a form of transcranial current stimulation that is similar to temporal interference stimulation (TIS) but lacks focality and steerability, yet has been key to understanding its neurophysiological effects in humans. For example, recent experimental results showed that TMS pulses time locked to tACS over motor cortex induced MEP amplitude modulation that was dependent on the phase of the tACS oscillatory currents. Building on this finding, the investigators will provide TMS pulses to motor cortex during tTIS and investigate whether neuromodulation of corticospinal excitability depends on the phase of beat frequency (fb). Similar to the experiments that showed neural activation in mice, the investigators will also investigate whether the strength of the effect depends on the carrier frequency (fc). The investigators will use computationally optimized electrode placement, with high- and low-frequency controls, to test that effects are unambiguously due to fb. Finally, the investigators will assess corticospinal excitability PRE and POST stimulation to investigate neuroplasticity induced by TIS. The knowledge gained in this experiment will demonstrate the extent to which modulation effects of TIS in humans are due entrainment of neural activity at fb. This information will provide a basis for the future use of tTIS for clinical applications.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Joanne Hall, M.Sc.
- 전화번호: 17027828483
- 이메일: hall.joa@northeastern.edu
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115-5724
- 모병
- Northeastern University
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연락하다:
- Mathew Yarossi, PhD
- 전화번호: 7027828483
- 이메일: m.yarossi@northeastern.edu
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수석 연구원:
- Mathew Yarossi, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Free of neurological or orthopedic conditions that may impact the ability to participate.
- Right-hand dominant (self-reported)
- Aged 18-65 years
Exclusion Criteria:
- Ferromagnetic metal implants in the brain/skull or elsewhere (dental implants excluded).
- Any implanted electronic device (e.g. cardiac pacemaker, cochlear implant, deep brain stimulator, medication infusion pump; vagal nerve stimulator)
- Diseased or damaged skin on face or scalp
- History of migraines, fainting, seizures/epilepsy, or psychiatric illness
- Neurological disorder or intracranial lesion
- Frequent or severe headaches
- Prior adverse reaction to transcranial magnetic stimulation
- Currently pregnant
- Suspected or diagnosed heart problems (e.g. arrhythmia, cardiac disturbances).
- Insulin-dependent diabetes
- Suspected or diagnosed epilepsy or a familial history of epilepsy
- Use of alcohol or recreational drugs in the prior 12 hours
- Use of prescription and over the counter medications will be grounds for exclusion except for: contraceptive (birth control) drugs (e.g. those containing ethinyl estradiol and/or norethindrone), and seasonal allergy medications (e.g. cetirizine (Zyrtec), fexofenadine (Allegra), and loratadine (Claritin)).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 990-1010 Hz fb
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We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
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실험적: 1990-2010 Hz fb
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We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
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실험적: 1000-1000 Hz fb
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We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
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실험적: 2000-2000 Hz fb
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
|
실험적: 20 Hz
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
|
가짜 비교기: sham
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Online phase-dependent modulation of corticospinal excitability using the relevance value (R.V.)
기간: Periprocedural
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Explained variance (R2) of best-fit sinusoids will be multiplied by the variance of measured values to obtain the established "relevance value" (R.V.), to be used as our primary outcome.
Relevance values assume phase-dependent modulation with a large amplitude is more meaningful than one with small amplitude and the same R2.
Critically, phase-dependent responses to TIS represent direct evidence of modulation at beat frequency (fb).
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Periprocedural
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Offline neuroplastic effects from pre to post
기간: Periprocedural
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We define neuro- plastic effects as sustained modulation of excitability fol- lowing cessation of transcranial current sitmulation (tCS).
Fifteen single-pulse MEPs will be acquired at the FDI hotspot prior to and at 0, 15 and 30 minutes after tCS (tpre, t0, t15, t30).
Our primary outcome will be MEP amplitude change from tpre to t0.
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Periprocedural
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Offline neuroplastic post effects
기간: Periprocedural
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Retention of neuromodulation at t15 and t30.
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Periprocedural
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mathew Yarossi, PhD, Northeastern University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 25-02-54
- 5R01NS133229 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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